An FDA advisory panel voted 16-0 with one abstention on Wednesday that Novo Nordisk's GLP-1 analogue semaglutide should be approved for use in adults with type 2 diabetes. The vote follows an FDA staff report earlier this week that concluded semaglutide is effective with no associated cardiovascular (CV) risk. The agency is expected to issue a final decision regarding whether to approve the once-weekly injection by December 5.
Commenting on the news, BMO Capital Markets analyst Alex Arfaei suggested that, if approved, "semaglutide will be a formidable competitor" to Eli Lilly's GLP-1 receptor agonist Trulicity (dulaglutide), a once-weekly injection that was approved in the US and the EU in 2014. Analysts anticipate sales of semaglutide to reach about $3.2 billion by 2023, versus $3.7 billion for Trulicity. Todd Hobbs, Novo Nordisk's chief medical officer, recently declined to disclose how much the company planned to charge for its therapy.
Novo Nordisk's FDA filing for semaglutide, which is also under review in Europe and Japan, was supported by data from the SUSTAIN development programme consisting of eight late-stage studies that involved more than 8000 adults with type 2 diabetes. Data from the SUSTAIN 6 cardiovascular outcomes trial released last year showed that semaglutide significantly reduced the risk of CV events versus placebo in patients with type 2 diabetes at high CV risk.
FDA advisory panel members also discussed data suggesting that semaglutide was associated with an initial worsening of diabetic retinopathy, but they concluded that the overall benefit of reducing blood glucose levels offset this risk, which the company has argued is temporary. Analysts expect the drug's label to carry a standard warning, similar to insulins, regarding diabetic retinopathy.
Novo Nordisk chief science officer Mads Krogsgaard Thomsen stated "semaglutide has demonstrated the potential to improve the treatment of type 2 diabetes and the positive recommendation from the advisory committee marks an important step towards making semaglutide available to adults with type 2 diabetes in the US." He added "we look forward to working with the FDA as they complete their review of semaglutide."
For related analysis, see ViewPoints: Semaglutide should deliver for Novo Nordisk, but it may only be the aperitif and ViewPoints: Novo Nordisk's semaglutide ticks all the boxes. See also Physician Views Poll Results: Trulicity appears to have a semaglutide-sized problem.
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