PLAINSBORO, N.J., Dec. 5, 2016 /PRNewswire/ -- Novo Nordisk
today announced the submission of a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for semaglutide, a
glucagon-like peptide-1 (GLP-1) analog administered once-weekly,
for the treatment of adults with type 2 diabetes. The company
also submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for semaglutide.
The submission is based on the results from the SUSTAIN clinical
trial program which included more than 8,000 adults with type 2
diabetes. In the SUSTAIN program, once-weekly semaglutide was
studied in combination with oral-antidiabetic agents and in
combination with basal insulin. Semaglutide demonstrated
statistically significant and sustained blood glucose control
compared to sitagliptin, exenatide extended-release, once-daily
insulin glargine U100 and placebo. Weight loss, a secondary
endpoint, was also demonstrated in all semaglutide arms of the
SUSTAIN program. Furthermore, the cardiovascular outcomes
trial, SUSTAIN 6, demonstrated a cardiovascular risk reduction
compared to placebo, as add-on to standard of care in patients with
high cardiovascular risk.
Across the SUSTAIN clinical trial program, the most common
adverse events >5% were nausea, vomiting, diarrhea, abdominal
pain and constipation.
"Achieving blood glucose control, weight loss and reducing the
risk of cardiovascular events remains a significant challenge for
adults with type 2 diabetes," said Mads
Krogsgaard Thomsen, executive vice president and chief
science officer of Novo Nordisk. "We are excited with this
regulatory filing as results from the SUSTAIN program show that
once-weekly semaglutide has the potential to offer further
improvement for adults in their treatment of type 2 diabetes."
About semaglutide
Semaglutide is a once-weekly analog of human GLP-1 that
stimulates insulin and suppresses glucagon secretion in a
glucose-dependent manner. Novo Nordisk intends to make semaglutide
available in a prefilled delivery device based on the same
technology platform as FlexTouch®.
About the SUSTAIN phase 3a clinical trial program
SUSTAIN (Semaglutide Unabated Sustainability in Treatment of
Type 2 Diabetes) is a global clinical trial development program for
the treatment of type 2 diabetes. The study was comprised of
eight Phase 3a studies of semaglutide encompassing more than
8,000 subjects around the globe.
About Novo Nordisk
Novo Nordisk is a global health
care 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.
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SOURCE Novo Nordisk