Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the US
(Thomson Reuters ONE) -
Bagsværd, Denmark, 29 March 2017 - Novo Nordisk today announced that the company
has resubmitted the new drug application (NDA) for fast-acting insulin aspart as
a class II re-submission to the US Food and Drug Administration (FDA).
In October 2016, Novo Nordisk announced that it had received a Complete Response
Letter from the FDA regarding the NDA for fast-acting insulin aspart. In the
letter, the FDA requested additional information related to the assay for the
immunogenicity and the assay used to generate the clinical pharmacokinetics data
before the review of the NDA could be completed. Novo Nordisk has now evaluated
the content of the Complete Response Letter and completed the End-of-Review
meeting with FDA; based on this, Novo Nordisk has resubmitted the fast-acting
insulin aspart NDA as a class II re-submission.
Novo Nordisk expects to receive feedback from the FDA in the last quarter of
2017.
About fast-acting insulin aspart
Fast-acting insulin aspart is a mealtime insulin for the control of postprandial
glucose excursions in type 1 and type 2 diabetes as well as in pump treatment.
Fast-acting insulin aspart is insulin aspart (NovoLog(®)/NovoRapid(®)) in a new
formulation in which two new excipients have been added to ensure early and fast
absorption. Fast-acting insulin aspart received marketing authorisation from the
European Commission on 9 January 2017, covering all 28 European Union member
states. Approvals were also received in Norway, Iceland and Canada. It is also
currently under regulatory review in Switzerland, Australia, Brazil, South
Africa, Argentina and Israel.
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
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Anders Mikkelsen +45 3079 4461 armk(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 24 / 2107
PR170329_Fiasp US resubmission_UK:
http://hugin.info/2013/R/2091682/790421.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: 29.03.2017 - 16:51 Uhr
Sprache: Deutsch
News-ID 533246
Anzahl Zeichen: 2876
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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