Bagsværd, Denmark 7 October 2016 - Novo Nordisk today announced that it has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Application for faster-acting insulin aspart.
In the letter, the FDA requests additional information related to the assay for the immunogenicity and clinical pharmacology data before the review of the New Drug Application can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to resolve the 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", says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We acknowledge the request for information from FDA and will work closely with the agency to determine the best path forward to complete the review."
The New Drug Application for faster-acting insulin aspart was submitted to the FDA in December 2015. Faster-acting insulin aspart is currently also under review in the EU, Switzerland, Canada, Brazil, South Africa and Argentina.
|Katrine Sperling||+45 3079 6718||[email protected]|
|Ken Inchausti (US)||+1 609 786 8316||[email protected]|
|Peter Hugreffe Ankersen||+45 3075 9085||[email protected]|
|Melanie Raouzeos||+45 3075 3479||[email protected]|
|Hanna Ögren||+45 3079 8519||[email protected]|
|Kasper Veje (US)||+1 609 235 8567||[email protected]|
Company announcement No 69 / 2016
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via Globenewswire