Semaglutide receives positive 16-0 vote in favour of approval from FDA Advisory Committee
(Thomson Reuters ONE) -
Bagsværd, Denmark, 18 October 2017 - Novo Nordisk today announced that
the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food
and Drug Administration (FDA) voted 16-0 in favour of the approval of once-
weekly semaglutide to improve glycaemic control in adults with type 2 diabetes.
One member of the committee abstained.
Based on the data included in the New Drug Application (NDA) for semaglutide,
the FDA asked the panel members to discuss whether Novo Nordisk has provided
adequate evidence to establish the efficacy and safety profile of semaglutide
for the treatment of type 2 diabetes in adults.
The recommendation for approval was based on a global development programme
involving more than 8,000 adults with type 2 diabetes in the eight SUSTAIN phase
3a clinical trials, including a cardiovascular outcomes trial.
"Semaglutide has demonstrated the potential to improve the treatment of type 2
diabetes and the positive recommendation from the Advisory Committee marks an
important step towards making semaglutide available to adults with type 2
diabetes in the US. We look forward to working with the FDA as they complete
their review of semaglutide," said Mads Krogsgaard Thomsen, executive vice
president and chief science officer.
The NDA for once-weekly semaglutide was submitted to the FDA in December 2016
under the US FDA's Prescription Drug User Fee Act V (PDUFA V) regulation.
Semaglutide is currently under review by several regulatory agencies, including
the European Medicines Agency and the Japanese Pharmaceuticals and Medical
Devices Agency.
Conference call
On 19 October 2017 at 8.00 am CEST (2.00 am EDT), Novo Nordisk will host a
conference call for investors. Investors will be able to listen in via a link on
the investor section of novonordisk.com/investors.
About advisory committees
FDA advisory committees are panels of independent experts who advise the FDA on
specific questions raised by the FDA as they consider regulatory decisions. The
FDA is not bound by the committee's recommendation, but it takes its advice into
consideration when reviewing data concerning the safety and efficacy of marketed
drugs or new drug applications.
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
Christina Kjær +45 3079 3009 cnje(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 80 / 2017
PR171018_Semaglutide_adcom_UK:
http://hugin.info/2013/R/2142854/820949.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: 18.10.2017 - 23:22 Uhr
Sprache: Deutsch
News-ID 564279
Anzahl Zeichen: 3615
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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