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October 19, 2017

Novo Nordisk Wins FDA Panel Recommendation for Once-Weekly Diabetes Candidate Semaglutide

  • Novo Nordisk is on track to win FDA approval later this year to market the first once-weekly type 2 diabetes treatment following an advisory committee’s unanimous recommendation yesterday in favor of the company’s semaglutide.

    The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 16 to 0, with one abstention, to recommend approval of Novo Nordisk’s semaglutide, concluding that the glycemic control injection treatment was safe and effective.

    The FDA usually, but not always, follows the recommendations of its advisory committees. Semaglutide is under Priority Review with the agency, which has assigned a Prescription Drug User Fee Act (PDUFA) target decision date of December 5, 2017.

    “We look forward to continuing to work with the FDA as they complete their review of semaglutide,” Todd Hobbs, M.D., VP and U.S. CMO of Novo Nordisk, said in a statement. “Semaglutide has the potential to impact the lives of people with type 2 diabetes by helping to meaningfully reduce A1c. This treatment option may also help people lose weight.”

    Semaglutide is an investigational analog of native human glucagon-like peptide-1 (GLP-1) deemed suitable for once-weekly dosing due to its high albumin binding, resulting in a long half-life of approximately one week. As with other GLP-1 receptor agonists (GLP-1 RAs), once-weekly administration of semaglutide stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, according to Novo Nordisk.

    Novo Nordisk submitted its NDA for once-weekly semaglutide to the FDA in December 2016.

    The FDA panel recommendation for approval was based on data from SUSTAIN, a global development program that evaluated the safety and efficacy of semaglutide, administered once weekly. The global SUSTAIN Phase IIIa clinical trial program consisted of eight clinical trials—one of them a two-year cardiovascular outcomes trial—involving more than 8000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, with and without renal disease.

    Novo Nordisk is hoping to begin marketing semaglutide starting next year, with analysts in published reports estimating the treatment will generate annual sales of $2 billion.

    Novo Nordisk’s best-selling diabetes treatment after insulin and modern insulin, the once-daily Victoza® (liraglutide), generated DKK 20.046 billion ($3.2 billion) in sales last year, up 12% in local currencies from 2015—and according to Novo Nordisk finished 2016 as market leader among GLP-1 treatments with a 58% share. Last year, Novo Nordisk launched another once-daily diabetes treatment Tresiba® (insulin degludec), a new-generation once-daily basal insulin that racked up DKK 4.056 billion ($645 million).

    However, Victoza and Tresiba face growing competition from Eli Lilly’s once-weekly diabetes treatment Trulicity® (dulaglutide), which is headed for billion-dollar-a-year “blockbuster” status after finishing 2016 with $925.5 million in revenue, more than triple the $248.7 million of 2015. Another once-weekly competitor, AstraZeneca’s Bydureon® (exenatide extended-release), generated $578 million in 2016 sales.

    Semaglutide is currently also under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

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