Novo gains FDA OK for semaglutide
- The Food and Drug Administration approved Novo Nordisk A/S’ once-weekly glucagon-like peptide (GLP)-1 agonist semaglutide for type 2 diabetes.
- The drug will be marketed under the name Ozempic, and was approved in two doses; 0.5 mg and 1 mg. Ozempic will be launched in a prefilled pen device.
- As part of a post-marketing requirement, Novo Nordisk will conduct a trial in patients under 18 years old. It will also add Ozempic to the 15-year MTC (medullary thyroid carcinoma) registry that is being conducted for all GLP-1s.
Novo Nordisk, one of the largest companies in the diabetes space, has been struggling to compete as the therapeutic area becomes overcrowded with multiple drug options in each class, and pricing controls put pressure on the market.
Novo currently has the market leading GLP-1 in the space, its once-daily Victoza (liraglutide). But multiple other entrants have entered the class, including long-acting options that improve adherence and ease of use. While Victoza has maintained its leadership position, its market share has been growing smaller with each new GLP-1.
The entrance of Ozempic will give Novo the tool it needs to maintain market share. It will also allow for the company to put in place a lifecycle management plan for its GLP-1 offerings that has patients switching from Victoza to Ozempic, giving Novo a buffer for when Victoza loses patent protection in 2023.
The approval was based on results from the SUSTAIN clinical trial program and had backing of an FDA advisory committee. The SUSTAIN trials compared Ozempic to other widely used drugs in the space, including the insulin Lantus, the DPP-4 inhibitor Januvia (sitagliptin) and the extended release GLP-1 Bydureon (exenatide).
"We are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the U.S. with type 2 diabetes in the beginning of 2018," said Chief Scientific Officer Mads Krogsgaard Thomsen.
- Novo Nordisk Statement
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