FDA staff determine that Novo Nordisk's semaglutide is effective, has no heart risks

In documents published Monday ahead of an FDA advisory committee meeting on October 18, agency reviewers said that Novo Nordisk's semaglutide is effective and does not cause heart problems. The company is seeking approval of the GLP-1 analogue for the treatment of type 2 diabetes in adults.

In clinical data unveiled in 2015, semaglutide was associated with superior improvements in HbA1c and weight loss versus placebo. Meanwhile, in a subsequent Phase III study, the therapy, when added to standard of care, was linked to a 26-percent reduction in the risk of cardiovascular events compared to placebo.

According to the FDA reviewers, data from clinical trials of semaglutide "supports the claim" of using the drug to improve blood glucose control in patients with type 2 diabetes. The staff noted that there was an increase in the number of people who developed sight problems, although they concluded there was "no reason to restrict semaglutide with respect to population or dosing schedule."

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.

Novo Nordisk submitted semaglutide for approval in the US and EU for the treatment of type 2 diabetes in December 2016. The once-weekly therapy is also under review in other markets, including Japan.

In 2015, Novo Nordisk announced plans to invest $2 billion over a five-year period to build production facilities for semaglutide and other products in the US and Denmark. Analysts estimate that global annual sales of semaglutide will reach nearly $3.2 billion by 2023, with Danske Bank forecasting that the product will account for 32 percent of Novo Nordisk's revenue by 2025.

For related analysis, see ViewPoints: Novo Nordisk's semaglutide ticks all the boxes, and read Physician Views Poll Results: Trulicity appears to have a semaglutide-sized problem.

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