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@novonordisk.com |
| Ken Inchausti (US) | +1 609 786 8316 | kiau@novonordisk.com (mailto:mailtokiau@novonordisk.com) |
| Investors: | ||
| Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com (mailto:phak@novonordisk.com) |
| Hanna Ögren | +45 3079 8519 | haoe@novonordisk.com (mailto:haoe@novonordisk.com) |
| Anders Mikkelsen | +45 3079 4461 | armk@novonordisk.com (mailto:armk@novonordisk.com) |
| Kasper Veje (US) | +1 609 235 8567 | kpvj@novonordisk.com (mailto:kpvj@novonordisk.com) |
Company announcement No 24 / 2107
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
