Dive Brief:
- An advisory panel to the Food and Drug Administration on Wednesday recommended approval for a once-weekly injectable Type 2 diabetes drug developed by Novo Nordisk A/S, voting 16 to 0 in favor of the drug's efficacy and safety. One committee member abstained.
- Novo submitted the drug, a GLP-1 analog called semaglutide, for approval in both the U.S. and Europe last December based on results from a clinical trial program that included more than 8,000 patients in total. Results showed improved blood glucose control, as well as superior weight loss.
- Semaglutide is also pending approval in Japan and Novo Nordisk is developing an oral formulation —currently in Phase 3 study — which could be a competitive advantage if it succeeds.
Dive Insight:
GLP-1 analogs are a well-established class of drugs for Type 2 diabetes, with drugs from Novo, AstraZeneca plc and Eli Lilly & Co already on the marketplace.
Prior to the launch of Eli Lilly's Trulicity (dulaglutide), Novo's Victoza (liraglutide) was far and away the market leader, commanding a near 70% share of new prescriptions. Fast uptake for Trulicity, which is given once weekly rather than the once-daily dosing of Victoza, has substantially eroded that lead.
Intarcia Therapeutics, Inc. is also trying to make its mark im the space with ITCA 650, an implantable drug-device combo that delivers AstraZeneca's Byetta (exenatide) under the skin for months. A rejection from the Food and Drug Administration last month over manufacturing concerns, however, has temporarily set back Intarcia's hopes.
For Novo, semaglutide has shown strong clinical data, including head-to-head results favoring the experimental drug versus Trulicity in patients receiving metformin.
Approval of semaglutide would give Novo a once-weekly injectable option to compete with Trulicity and help gain back share. The FDA is expected to decide whether to OK the drug by December 5. While it is not required to follow the advice of its advisory panels, it usually does so.
Semaglutide's potential as an oral drug could be a further opportunity for Novo, but that isn't expected to launch until 2020.
A tightening market for diabetes drugs in the US has made success with semaglutide all the more important to the Danish drugmaker, which has been hit particularly hard by higher competition and pricing pressure.
Shares in Novo rose by 1.5% in Thursday morning trading on news of the panel vote.