Novo Nordisk's Ozempic approved by FDA as once-weekly therapy for type 2 diabetes

Novo Nordisk said Tuesday that the FDA has authorised the GLP-1 agonist Ozempic (semaglutide) as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The drugmaker indicated that the once-weekly therapy should carry a price of $676 per prescription, adding that the cost is "at parity" with similar products. Novo Nordisk chief science officer Mads Krogsgaard Thomsen remarked "we are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the US with type 2 diabetes in the beginning of 2018." 

The news comes after an FDA advisory committee backed approval of Ozempic for use in this population in October. In documents released ahead of the advisory panel meeting, FDA staff determined that the treatment is effective with no associated cardiovascular risk.  

FirstWord reports in this therapy area - KOL Insight Type 2 Diabetes Mellitus: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

Approval of the drug was supported by safety and efficacy data from the SUSTAIN clinical trial programme. In the SUSTAIN 6 cardiovascular outcomes study, the addition of Ozempic to standard of care significantly cut the risk of major cardiovascular events versus placebo. 

Analysts have forecast sales of Ozempic to reach nearly $3.2 billion by 2023, versus $3.7 billion for Eli Lilly's Trulicity (dulaglutide). Meanwhile, Credit Suisse analysts estimated that Novo Nordisk will capture about 60 percent of the GLP-1 market by 2022, compared to an estimate of 53 percent for the current year.

For related analysis, see ViewPoints: Semaglutide should deliver for Novo Nordisk, but it may only be the aperitif. See also, KOL Views Results: Leading clinician sees semaglutide as incremental improvement on Trulicity, with paradigm shift still to come.

To read more Top Story articles, click here.