Novo Nordisk (NVO) American depositary shares were sliding pre-market Monday after the drugmaker said late Friday it received a complete response letter from the Food and Drug Administration regarding a new drug application filed for faster-acting insulin aspart.
In the letter, the FDA said it will need additional information relating to the assay for immunogenicity and clinical pharmacology data before it can complete a review of the NDA. The Denmark-based company said it is evaluating the content of the letter and will work closely with the agency to resolve any outstanding issues.
“We believe faster-acting insulin aspart can address an unmet medical need for people requiring improved blood glucose control around meals, and our ambitions for this innovative drug are unchanged,” said Novo Nordisk chief science officer Mads Krogsgaard.
Novo Nordisk filed an NDA for faster-acting insulin to the FDA in Dec.