Merck Announces U.S. FDA Grants Tentative Approval for LUSDUNA™ Nexvue™ (insulin glargine injection), a Follow-On Biologi...
July 20 2017 - 7:30AM
Business Wire
Merck (NYSE:MRK), known as MSD outside of the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin
glargine injection) 100 units/mL, a follow-on biologic1 basal
insulin in a pre-filled dosing device. LUSDUNA Nexvue is being
developed by Merck with funding from Samsung Bioepis.
With the tentative approval, LUSDUNA Nexvue has met all required
regulatory standards for follow-on biologics of clinical and
nonclinical safety, efficacy and quality, but is subject to an
automatic stay due to a lawsuit from Sanofi claiming patent
infringement. Under the Hatch-Waxman Act, the initiation of
Sanofi’s lawsuit in September 2016 automatically invoked a stay on
final FDA approval of LUSDUNA Nexvue for a period of up to 30
months, or in the event a court finds in favor of Merck, whichever
comes sooner.
“The tentative approval of LUSDUNA Nexvue is an important
milestone, bringing us closer to offering this medicine to
patients,” said Sam Engel, M.D., associate vice president, Merck
clinical research, diabetes, endocrinology and women’s health.
The trade name “LUSDUNA Nexvue” was granted provisional approval
by the FDA and will be used in the U.S. when the product
is made available.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us
on Twitter, Facebook, Instagram, YouTube
and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2016
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
1 A follow-on biologic is a similar, but not identical, version
of an approved reference product. In the U.S., LUSDUNA Nexvue is
referred to as a follow-on biologic because of its regulatory
pathway.
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MerckMedia:Doris Li, 908-246-5701orKristen Drake,
908-740-6179orInvestors:Amy Klug, 908-740-1898
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