FDA Approves Novo Nordisk's Rybelsus Diabetes Tablets
21 September 2019 - 1:30AM
Dow Jones News
By Chris Wack
The U.S. Food and Drug Administration said Friday it approved
Novo Nordisk's (NVO) Rybelsus semaglutide oral tablets to improve
control of blood sugar in adult patients with type 2 diabetes,
along with diet and exercise.
The FDA said Rybelsus is the first glucagon-like peptide, or
GLP-1, receptor protein treatment approved for use in the U.S. that
doesn't need to be injected. GLP-1 drugs are non-insulin treatments
for people with type 2 diabetes.
The FDA said like GLP-1, Rybelsus slows digestion, prevents the
liver from making too much sugar, and helps the pancreas produce
more insulin when needed.
Novo Nordisk said it is working with health insurance providers
with a goal of ensuring broad insurance coverage and patient access
to the product. A savings card program will be available at the
time of launch for eligible commercially-insured patients to keep
out of pocket costs down to as little as $10 a month.
The FDA is still reviewing Novo Nordisk's new drug application
for Rybelsus, seeking an additional indication to reduce the risk
of major adverse cardiovascular events such as heart attack,
stroke, or cardiovascular death in adults with type 2 diabetes and
established cardiovascular disease. A decision is expected in the
first quarter of 2020.
Novo Nordisk said Rybelsus is currently under review by several
regulatory agencies around the world, including the European
Medicines Agency and the Japanese Pharmaceuticals and Medical
Devices Agency.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 20, 2019 11:15 ET (15:15 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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