Novo Nordisk receives Complete Response Letter in the US for faster-acting insulin aspart
(Thomson Reuters ONE) -
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(at)novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz(at)novonordisk.com
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 69 / 2016
PR161007_FasterActingAspart_CRL_UK:
http://hugin.info/2013/R/2047717/765486.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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
Unternehmensinformation / Kurzprofil:
Datum: 07.10.2016 - 23:52 Uhr
Sprache: Deutsch
News-ID 499475
Anzahl Zeichen: 2466
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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