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2016-10-07 23:51 CEST
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Novo Nordisk receives Complete Response Letter in the US for faster-acting insulin aspart

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.

Further information

Media:    
Katrine Sperling +45 3079 6718 krsp@novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com
 

Investors:
   
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com
Hanna Ögren +45 3079 8519 haoe@novonordisk.com
Kasper Veje (US) +1 609 235 8567  kpvj@novonordisk.com


Company announcement No 69 / 2016

HUG#2047717