From a baseline HbA1 of 8. Difficult. Today, the U. From a baseline HbA1 of 8. 1 . S. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and. ONWARDS 1 is a phase 3a, 78-week, open-label efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs. 31 In July 2021, the FDA granted approval of the first interchangeable biosimilar insulin product in the U. On August 23, 2021, FDA approved the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty, for the prevention of COVID-19. If tirzepatide were to get approved by the FDA, it is a huge win for Eli. And the trial? It was a randomised, double-blind, double-dummy, treat-to-target trial of once-weekly insulin icodec compared with once-daily insulin glargine U100* involving 247 insulin-naïve adults with type 2 diabetes who were unable to maintain euglycaemic levels with metformin. Additionally, biosimilar products are becoming more common and offer more cost-saving options for patients. New Drug. Instead, participants could use neutral protamine Hagedorn insulin for the last 24–48 h prior to the icodec administration. November 30, 2022. Today, the U. 66. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older and granted. 4 mmol/mol icodec LD) and 7. ) for patients with unresectable locally advanced or metastatic. (CSII) with or without bolus insulin or additional anti-diabetic drug(s). Today the U. From an overall baseline HbA 1c of 8. Ist die Insulinanlage von der FDA zugelassen?Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) Drug Approval Reports by Month. Between 9 May and 9 August 2019, 259 patients were screened, of whom 205 were randomized to one of the treatment groups (icodec titration A, n = 51; icodec titration B, n = 51; icodec titration C, n = 52; IGlar U100, n = 51) and received at least one dose of study drug (FAS, N = 205; SAS, N = 205) (Supplementary Fig. 13%, once-weekly insulin icodec achieved a superior reduction in estimated HbA 1 c of 0. globin level was −1. 71 percentage points with degludec. Some of these are new molecular entities while others are existing products with potential new indications, or different formulations. S. Bristol Myers Squibb and 2seventy bio, Inc. Icodec now awaits approval by the U. One such formulation is insulin icodec, with a half-life of 196 h, suitable for once-weekly administration. and other relevant documents were approved by the appropriate independent review boards or independent ethics committees. If approved, it will be the world’s first once-weekly insulin. New Delhi: World’s first once-a-week insulin, Icodec, by Danish pharma giant Novo Nordisk, may be available in India in 2025, the company’s corporate vice-president and India managing director Vikrant Shrotriya told ThePrint in an interview. Food and. The FDA approval is only the beginning to the commercialization, which is the part that really brings in revenue, so it is definitely an important factor to consider. 71. Once insulin icodec is approved for use, there will be some practical issues and concerns related to its clinical implementation. 3 treatment initiation Acquisition of Forma Therapeutics Inc. 9% (62. Cell & Gene Therapies . Develop and implement compliance policies, strategies and actions to ensure that prescription drugs marketed in the United States meet applicable new drug. (HealthDay) MONDAY, July 17, 2023 (HealthDay News) -- People with type 2 diabetes could soon have access to convenient once-a-week insulin shots that could. UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. A pair of studies presented at the 83rd Scientific Sessions of the American Diabetes Association highlights the potential of once-weekly insulin icodec in people with type 2 diabetes. Lisa Maragakis, M. After detailed deliberation the committee recommended grant of permission for manufacturing and marketing the drug. If the FDA gives the green light, the investigational drug will enter several phases of clinical trials and post-marketing approval: Phase 1: Phase 1 focuses on safety. In absolute terms, there were 0. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. 8 Obesity . 8 The extended half-life of icodec is achieved through modifications to the insulin molecule. FDA Office of Media Affairs. 30 and 0. Safety, metabolism and excretion of the drug are also emphasized. , senior director of infection prevention, and Gabor Kelen, M. It is a molecular-based test intended to. Insulin icodec is designed to have a prolonged PK profile with a slow and sustained glucose-lowering effect mainly due to reduced binding to insulin receptors and. The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA 1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. Based on the ONWARDS program me, patients with type 2 diabetes who are candidates for insulin icodec will include insulin – naïve patients and basal insulin – treated patients not achieving glyc a emic targets, especially when adherence to daily injections is a. Novo Nordisk A/S Novo Alle 1 2880 Bagsværd Denmark +45-4444-8888 CVR-no. "These data reinforce our confidence in the potential of once-weekly insulin icodec," said Florian M. 9 Following subcutaneous injection, icodec is absorbed into the circulation, where an essentially inactive albumin-bound depot of icodec is formed. Insulin icodec, a once-weekly, ultralong-acting basal insulin analogue is currently in development for the treatment of diabetes. If approved, insulin icodec will represent the first and only once-weekly basal insulin option for adults with diabetes, addressing an unmet need in treatment vs. The ongoing COMBINE and QWINT trials are expected to provide substantive evidence of the efficacy and safety of icodec + semaglutide and insulin efsitora alfa,. 2 mg Icodec submission Oral semaglutide 50 mg ph. Insulin icodec is a long-acting basal insulin analogue, intended for once-weekly treatment, being developed by Novo Nordisk, for the treatment of type 1 and First decisions are anticipated in H1 2024. Throughout the trial, insulin icodec was observed to have a safe and well-tolerated profile. Novo. Conclusions: Switching from daily basal insulin to once-weekly icodec was well tolerated and provided effective. Ildiko Lingvay, an endocrinologist at UT Southwestern Medical Center in Dallas. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. 12. Ildiko Lingvay, an endocrinologist at UT Southwestern Medical Center in. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017. On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc. 9%; estimated between-group difference. 2 . July 28, 2021. 1 . 0 mg EU approval Oral GLP-1/ GIP co-agonist Ph1 initiation Ozempic 2. The FDA approved 37 novel drugs in 2022, the fewest to pass regulatory scrutiny since 2016. 5 Geriatric Use . Furthermore, Novo Nordisk is awaiting approval for icodec, a potential once-weekly insulin product. You have a chance of qualifying for this trial. Pharmacodynamics 12. 64. , Ltd. 9 million people in the UK have diabetes, around 90% of which have type 2 diabetes, according to Diabetes UK. S. A company-sponsored study indicated the drug semaglutide used to treat type 2 diabetes might be effective for weight loss. Food and Drug Administration is expected to rule on icodec’s approval sometime this year. 8. Mechanism of Action 12. 1 trials initiated in NASH utilising the siRNA platform Ph. 9, 10 The strong. Topic. A series of ONWARDS trials to evaluate the efficacy and safety of insulin. 6 Renal Impairment 8. The FDA approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight with at. The product continues to be approved for. FDA Statement. 30 and 0. 1 . Elsewhere, the biotech is developing medicines for Alzheimer's disease, sickle cell disease, and. a daily basal insulin option 4-9. The FDA approved 53 novel drugs in 2020, the second highest count in over 20 years. 12% with glargine U100 [mean change, −1. Slovakia Type 2 Diabetes Insulin icodec - Drug. More information about the Pfizer-BioNTech COVID-19 Vaccine. This trial is conducted in Europe. Furthermore, Novo Nordisk is awaiting approval for icodec, a potential once-weekly insulin product. 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY . Insulin icodec is not yet approved by the FDA. Phase 2 studies compared once-weekly icodec to insulin glargine (U. Pending approval, insulin icodec will represent the first and only once-weekly basal insulin option for adults with diabetes, addressing an unmet need in treatment vs a daily basal insulin option. We would like to show you a description here but the site won’t allow us. a daily basal insulin option 4-9. D. The U. , the sum of free, unbound icodec and icodec bound to albumin) were measured using a validated icodec specific luminescence oxygen channelling immunoassay with a minimum required dilution of 50, an analytical range from 500 to 80,000 pmol/L, and quality controls having a cumulative accuracy from − 12. finerenone. We retrieved all the available granular details of phase 1 to phase 3 studies of insulin icodec in both type 1 and type 2 diabetes. Drug Trials Snapshot. S. In the second report, also involving insulin-naive patients with type 2 diabetes, three different titration strategies for insulin icodec were compared, along with an insulin glargine group (). Overall, 171 (59%) of 291 participants in the icodec group and 167 (57%) of 291 participants in the glargine U100 group had an adverse event. Given Farxiga’s dominance in the SGLT-2I space, a combination with GLP-1RA will have significant benefits for treating the co-morbidities of obesity. 1 trials initiated in NASH utilising the siRNA platform Ph. 15 percentage points in the glargine group, to estimated means of 6. Consumer: 888-INFO-FDA. Briumvi: ublituximab-xiiy. MONDAY, July 17, 2023 (HealthDay News) -- People with type 2 diabetes could soon have access to convenient once-a-week insulin shots that could replace the daily injections now required. Product ImageOctober 31, 2023. After 26 weeks, icodec. ch/42Y3SG5 #diabetes #MedTwitter. My two concerns will be the cost of the drug and whether the incidence of clinically important hypoglycemia will be higher during real-world use than during these carefully supervised clinical trials. Importance: Once-weekly insulin icodec could provide a simpler dosing alternative to daily basal insulin in people with type 2 diabetes. and elsewhere feel more comfortable,” he says. Not Available. S. Kerendia. The on-treatment period was defined as the period. 12. A once-weekly insulin formulation called icodec performed. to the icodec single dose, and participants who normally received once- or twice-daily basal insulin detemir or insu-lin glargine U100 discontinued their insulin treatment 24 h prior to the icodec single dose. GlobalData’s report assesses how Insulin icodec’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Seagen and Genmab’s tisotumab vedotin is a tissue-factor-targeted ADC. 2 mmol/L), one using weekly dose. 5% once-weekly insulin icodec achieved a superior reduction in estimated HbA 1c of -1. It is currently undergoing. This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. However, there is also an affordable insulin initiative by a nonprofit generic manufacturer (Civica Rx) that plans to develop and produce three biosimilar. Food and. jwat. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the. Route (s) of administration. A decision from the FDA is expected in April 2024. Today, the U. Rebyota is approved for the prevention of recurrence of. g. It expects to make regulatory filings in the U. Ph. 16 events per person-year of exposure with icodec and glargine U100, respectively, at week 52, and 0. S. It is currently undergoing phase 3 trials. CNN —. 2 (I) units. Researchers recently presented new clinical trial data on the safety and potential glucose-lowering effectiveness of two leading. Each year, CDER approves a wide range of new drugs and biological products: Some of these products have never been used in clinical practice. Researchers say semaglutide reduces appetite. With the potential to improve clinical outcomes and reduce the number of injections needed annually from 365 to 52 , insulin Icodec offers the potential to simplify insulin administration [Ref] . Food and Drug Administration based on these results, said lead researcher Dr. March 29, 2023. Implantable Pulse Generator. November 2020 und N Engl J Med 2020; 383:2107) . Tobacco Products. Insulin Icodec by Novo Nordisk Due to the possible risk in successful commercialization with ORMD-0801, the pipeline medication that may have a better chance with it is insulin icodec. November 2017. , director of the Johns Hopkins Office of Critical Event Preparedness and Response, explain what that means. $460. U. In weeks 74 to 78, this difference was maintained (70. Based on the ONWARDS programme, patients with type 2 diabetes who are candidates for insulin icodec will include insulin-naïve patients and basal insulin-treated patients not achieving glycaemic targets, especially. 44% to 7. Added: “or Medicare-approved telehealth” to High Utilization coverage criteria Removed: One (1) unit of service (UOS) per thirty (30) days. 1 initiated with once-weekly oral semaglutide Ph. 6 mmol/mol icodec NLD and IGlar U100); incidences and rates of AEs and hypoglycemic episodes were comparable. 22% superior reduction in estimated HbA1c compared with. After detailed deliberation the committee recommended grant of permission for manufacturing and marketing the drug. Otherwise, weekly insulin icodec had a well-tolerated profile. Insulin icodec (icodec) is a basal insulin analogue that has been developed for once-weekly subcutaneous administration in individuals with diabetes. New Drug. Site Archive. ) for patients with unresectable locally advanced or metastatic. Bagsværd, Denmark, 28 April 2022 – Novo Nordisk today announced headline results from the ONWARDS 2 trial, a phase 3a, 26-week efficacy and safety. Today, the U. Pediatric Use 8. Insulin icodec is a basal insulin analogue designed for once-weekly administration that is in development for the treatment of diabetes. 87%, respec-Here, similar findings were seen among a 588-participant group comparing once-weekly icodec to once-daily insulin degludec in insulin-naïve patients with type 2 diabetes. 8. For a protein drug, multimers with an absorption time longer than a week may not be desirable due to the risk of reduced bioavailability. S. The protocol, consent form, and other relevant documents were approved by the appropriate independent review boards or independent ethics committees. Food and Drug Administration amended the emergency. Background. S. ) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or. 93 percentage points over 26 weeks, compared to 0. 10 OVERDOSAGE 11 DESCRIPTION . 10,11 In phase 2 trials, onceweekly icodec showed similar improvements in glycaemic control and safety profiles versus oncedaily insulin glargine U100 in people with type 2 diabetes, withThe CGM is prescribed in accordance with its FDA indications for use; and, The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:. Researchers hope it can answer more questions about the safety and efficacy of the drug as well as reveal any negative side effects and show how. started insulin aspart on the same day or after the last dose of trial drug, and one participant (icodec NLD) started insulin aspart on day 30. Media: FDA Office of Media Affairs. 4 Pediatric Use 8. 7 Hepatic Impairment . FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed. 13. It expects to make regulatory filings in the U. This is a. A clinical pharmacology trial demon-strates that insulin icodec has a half- life of 196 hours andInsulin icodec is designed to have a prolonged PK profile with a slow and sustained glucose-lowering effect mainly due to reduced binding to insulin receptors and. , EU and China. Drug created at May 04, 2021 13:19 / Updated at May 05, 2021 20:33 . 31%-points for the once-daily basal. Geriatric Use . Insulin icodec is an investigational “ultra-long-acting” insulin with a 1-week half-life and dosing interval. GlobalData predicts that AstraZeneca has the potential to. Dr. Treatment for: Breast Cancer. 0% and 9. In people with long-standing type 2 diabetes on a basal-bolus regimen, once-weekly icodec showed similar improvements in glycaemic control, with fewer basal insulin injections, lower bolus insulin dose, and. Despite the disruptions caused by COVID-19, the FDA’s Center for Drug Evaluation and Research (CDER) approved. To reduce the risk of kidney and. Unlock growth opportunities with our. About FDA Product Approval. FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants. 87%, respec- Here, similar findings were seen among a 588-participant group comparing once-weekly icodec to once-daily insulin degludec in insulin-naïve patients with type 2 diabetes. Last year the FDA’s Center for Drug Evaluation and Research (CDER) approved 37 novel drugs. During the final 3 weeks of icodec treatment, while at steady state, the icodec glucose-lowering effect was assessed in three glucose clamps (target 7. 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8. 68%-points compared with -1. The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses. Objective: To evaluate the efficacy and safety of once-weekly icodec vs once-daily insulin degludec in people with insulin-naive type 2 diabetes. Insulin icodec, which is not yet FDA-approved, is considered “ultra long–acting,” with a 1-week half-life and once-weekly dosing (NEJM JW Gen Med Nov 15 2020 and N Engl J Med 2020; 383:2107). Mark has long been the most closely involved in the entire process of drug approval. S. Consumer: 888-INFO-FDA. 7 Hepatic Impairment . Danish diabetes care giant Novo Nordisk (NOV: N) on Sunday released positive new data from the Phase IIIa ONWARDS 1 and 3 trials evaluating investigative once-weekly basal insulin icodec at the. Mechanism of Action 12. Today, the U. ADC Therapeutics’s loncastuximab tesirine is a CD19-targeted ADC, for B-cell lymphoma. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older. a daily basal insulin option 4-9. An amount you have to pay for covered services and items each year before Medicare or your plan starts to pay. It was approved by the FDA in 2020 and launched in August 2020. The percentage of time spent in the glycemic range of 70 to 180 mg per deciliter was significantly higher with icodec than with glargine U100 (71. The product continues to be approved for. Griffin, MB, BCh, BAO, MSc, Dip Clin Ed, and Sean F. For pharmaceutical companies hoping to win regulatory approval for a drug, time really does mean money. Novo Nordisk expects to file for regulatory approval of once-weekly insulin icodec in the US, the EU and China in the first half of 2023. More than 4. Bagsværd, Denmark, Sunday 25 June 2023 – Novo Nordisk today announced data from the phase 3a ONWARDS 1 and 3 trials evaluating investigative. Pharmacodynamics 12. Approval Year Unknown. The study was published in the Nov. Name Type. Novo Nordisk targets FDA approval for once-weekly insulin after Phase III data - Pharma Technology Focus | Issue 125 | December 2022 ONWARDS 1 is a 78-week trial comparing the efficacy and safety of once-weekly insulin icodec with once-daily insulin glargine U100 both in combination with non-insulin anti-diabetic treatment in 984 insulin-naïve people with type 2 diabetes. UNII availability does not imply any regulatory review or approval. 8. Insulin pumps to date have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or approved by the FDA as part of a single, predefined diabetes management system. Our medicines are for the approved indication for which they are authorised in the local country or region. 31%-points for once-daily basal insulins. 16 per person-year of exposure, respectively, at week 83 (estimated rate ratios, 1. 12 CLINICAL PHARMACOLOGY 12. On August 23, 2021, FDA approved the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty, for the prevention of COVID-19. Given Farxiga’s dominance in the SGLT-2I space, a combination with GLP-1RA will have significant benefits for treating the co-morbidities of obesity. 12. AstraZeneca’s ECC5004 GLP-1RA therapy is currently in Phase I with the company reporting Phase II to begin in late 2023 or early 2024. The primary hypothesis was that icodec was non-inferior to degludec in terms of change from baseline to week 26 in HbA 1c using a non-inferiority margin of 0·3 percentage points, in accordance with US Food and Drug Administration guidance for industry on developing drugs for treatment of diabetes; this margin provides sufficient. With the full set of icodec trials having read out, Novo can continue onwards to its hoped-for approval. Today, the U. New Indications and Dosage Forms for 2023. ONWARDS 3 is a 26-week trial comparing once-weekly insulin icodec with once-daily insulin degludec. Today, the U. A: Investigational New Drug (IND) -- Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. At a glance Originator Novo Nordisk Class. The FDA says that Paxlovid is the fourth drug and first pill to be approved for the treatment of Covid-19. View duration, location, compensation, and staffing details. Introduction: Insulin icodec is a novel, long-acting insulin analog designed to cover basal insulin requirements with once-weekly subcutaneous administration. 9 million people in the UK have diabetes, around 90% of which have type 2 diabetes, according to Diabetes UK. Insuman (insulin 287) is a protein pharmaceutical. Novo Nordisk has announced headline results from the ONWARDS 5 phase 3a trial with once-weekly insulin icodec in people with type 2 diabetes, a 52-week study comparing once-weekly insulin. May 13, 2022. H. We would like to show you a description here but the site won’t allow us. The Food and Drug Administration (FDA or Agency) is announcing a virtual public meeting to discuss the proposed. Today, the U. Similar to icodec, efisitora is administered once weekly; it has a half-life of 17 days compared to 7-8 days for icodec. 8 Icodec has strong and reversible albumin-binding properties along with reduced insulin receptor binding affinity, result-ing in an essentially inactive circulating albumin-bound depot fromFDA Evaluation of Available Safety Data The available safety data to support the EUA include more than 4,600 participants (3,100 vaccine, 1,538 placebo) ages 5 through 11 years enrolled in the. FDA-approved use on approval date* 37. Once insulin icodec is approved for use, there will be some practical issues and concerns related to its clinical implementation. Figure 2. Novo Nordisk expects to file for regulatory approval of once-weekly insulin icodec in the US, the EU and China in the first half of 2023. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. The drug approval process takes place within a structured framework that includes: Analysis of the target condition and available treatments —FDA reviewers analyze the condition or illness for. Date of Approval: November 16, 2023. Radiation-Emitting Products. Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) Drug Approval Reports by Month. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Eclipse Images/Getty Images. FDA Office of Media Affairs. 3 read-out Concizumab ph. 50% to 6. This is the first coronavirus vaccine approved by the FDA. Materials and methods: Six randomized controlled trials have been initiated in adults with type 2 diabetes (T2D) (insulin-naive: ONWARDS 1, 3. Belinostat, a histone deacetylase (HDAC) inhibitor was granted accelerated approval in July 2014. (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose). Easy. Australia’s approval of these drugs, Doblin says, may only expedite the approval process in the U. 0 mg doses for the treatment of type 2 diabetes in adults. 10 OVERDOSAGE 11 DESCRIPTION . , director of the Johns Hopkins Office of Critical Event Preparedness and Response, explain what that means. FDA evaluation is the next step. In 2007, Biogen Idec’s total revenues grew 18 percent over 2006 to almost $3. Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. In these two industry-sponsored studies, researchers compared insulin icodec and insulin glargine. and elsewhere feel more comfortable,” he says. Dr. A new treatment for amyotrophic lateral sclerosis, or ALS, has been approved by the US Food and Drug Administration. Importance: Once-weekly insulin icodec could provide a simpler dosing alternative to daily basal insulin in people with type 2 diabetes. It has a plasma half-life more than eight days [1] (compared to 25 hours of the previous longest-acting insulin analogue insulin degludec ), making it a once-weekly basal insulin. Tobacco Products. Food and Drug Administration approved a new insulin product, indicated to improve glycemic control in adult and pediatric patients. It has a plasma half-life more than eight days (compared to 25 hours of the previous longest-acting insulin analogue insulin degludec), making it a. gov. A cartridge of insulin is put in the inhaler. once-daily insulin glargine U100, both in combination with non-insulin anti-diabetic treatment, in 984 insulin-naïve adults with type 2 diabetes. Baeres, corporate vice president of Global Medical Affairs at Novo Nordisk. Ozempic is now approved in the United States at 0. 90]), which translated. According to GlobalData, Pre-Registration drugs. S. Consumer: 888-INFO-FDA. ) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or. If approved, insulin icodec could be a major competitor for Sanofi’s Lantus, which was greenlit by the U. 1/20/2023. NexoBrid: anacaulase-bcdb. 3 .