The U.S. Food and Drug Administration has declined to approve Novo Nordisk's weekly insulin in patients with diabetes, the Danish drugmaker said on Wednesday.
The health regulator in its so-called "complete response letter" sought more information related to the manufacturing process and the type 1 diabetes indication to complete the review, Novo said.
Novo said it does not expect to be able to fulfil the requests this year, and that it will work closely with the FDA regarding the next steps.
The regulator's decision follows its outside panel's vote against the use of the weekly insulin icodec, in patients with type 1 diabetes due to risks of low blood sugar.
https://www.yahoo.com/news/us-fda-declines-approve-novo-220038190.html
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