The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for diabetes treatment due to concerns about manufacturing and use in type 1 diabetes patients. The company does not expect to fulfill the FDA’s requests this year. The FDA previously convened a panel of advisers who voted against approval for type 1 patients, citing concerns about potential risks of low blood sugar. Novo Nordisk had submitted the drug application for both type 1 and type 2 patients. The decision marks a rare setback for the pharmaceutical giant.
Source link
Novo Nordisk’s weekly insulin rejected by FDA
