PLAINSBORO, N.J., Oct. 18, 2017 /PRNewswire/ -- Novo
Nordisk today announced that the Endocrinologic and Metabolic Drugs
Advisory Committee (EMDAC) of the U.S. Food and Drug Administration
(FDA) voted 16-0, supporting the approval of once-weekly
semaglutide to improve glycemic control in adults with type 2
diabetes. One member of the committee abstained.
Based on the data contained in the New Drug Application (NDA)
for semaglutide, the FDA asked the panel members to discuss whether
Novo Nordisk has provided adequate evidence to demonstrate the
efficacy and safety profile of semaglutide for the treatment of
type 2 diabetes in adults.
The recommendation for approval was based on data from SUSTAIN,
a comprehensive global development program that evaluated the
safety and efficacy of semaglutide, administered once-weekly. The
global SUSTAIN Phase 3a clinical trial program comprised eight
clinical trials (one of which was a 2-year cardiovascular outcomes
trial), involving more than 8,000 adults with type 2 diabetes,
including adults with high cardiovascular risk profiles, with and
without renal disease.
"Semaglutide has the potential to impact the lives of people
with type 2 diabetes by helping to meaningfully reduce A1c. This
treatment option may also help people lose weight," said Todd
Hobbs, vice president and U.S. chief medical officer of Novo
Nordisk. "We look forward to continuing to work with the FDA as
they complete their review of semaglutide."
The NDA for once-weekly semaglutide was submitted to the FDA in
December 2016 under the U.S. FDA's
Prescription Drug User Fee Act V (PDUFA V) regulation. Semaglutide
is currently also under review by the European Medicines Agency and
the Japanese Pharmaceuticals and Medical Devices Agency.
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.
About semaglutide
Semaglutide is an investigational
analog of native human glucagon-like peptide-1 (GLP-1) and, through
its high albumin binding resulting in a long half-life of
approximately one week, semaglutide is suitable for once-weekly
dosing. Like other GLP-1 receptor agonists (GLP-1 RAs),
semaglutide, administered once-weekly, stimulates insulin and
suppresses glucagon secretion in a glucose-dependent manner.
About Novo Nordisk
Novo Nordisk is a global
healthcare company with more than 90 years of innovation and
leadership in diabetes care. This heritage has given us experience
and capabilities that also enable us to help people defeat other
serious chronic conditions: hemophilia, growth disorders and
obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly
5,000 employees in the United
States. For more information, visit novonordisk.us or follow
us on Twitter: @novonordiskus.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2017 Novo Nordisk All rights
reserved.
USA17SEM02889 October 2017
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SOURCE Novo Nordisk