The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.
This comes after the FDA in May convened a group of advisers to discuss the drug, called icodec. The panel voted against approval in type 1 patients, raising concerns about the risk of dangerously low blood sugar in that population.
