Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic I...
August 05 2016 - 8:00AM
Business Wire
Marketing Authorization Application to the
European Medicines Agency Currently Under Review
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 accepted for review the New Drug Application (NDA) for
MK-1293, an investigational follow-on biologic1 insulin glargine
candidate for the treatment of people with type 1 and type 2
diabetes, which is being developed by Merck with partial funding
from Samsung Bioepis.
“The FDA acceptance of our follow-on biologic application is an
important milestone, and brings us closer to offering another
treatment option for people in the U.S. with diabetes,” said Peter
Stein, M.D., vice president, late stage development, diabetes and
endocrinology, Merck. “We are proud of the significant
contributions we have already made to helping people with type 2
diabetes, and with investigational MK-1293, we hope to expand our
portfolio into insulin therapeutics and treatments for people with
type 1 diabetes.”
The development program for MK-1293 was designed to meet
rigorous regulatory standards for follow-on biologics of clinical
and nonclinical safety, efficacy and quality. In addition to Phase
1 studies assessing its pharmacokinetic and pharmacodynamic
properties, the NDA submission for MK-1293 includes results of two
Phase 3 studies, one conducted in
people with type 1 diabetes, and one in people with type 2
diabetes; Lantus® (insulin glargine)2, the originator insulin
glargine, was the active comparator in both studies.
The NDA was filed through the 505(b)(2) regulatory pathway3,
which allows the FDA to reference previous findings of safety and
efficacy for an already-approved product (Lantus), in addition to
reviewing findings from studies of MK-1293. Separately, the
Marketing Authorization Application for MK-1293, which Merck
submitted to the European Medicines Agency in December 2015, is
currently under review.
About Merck
For 125 years, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
the United States and Canada. 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. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, 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 2015
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., MK-1293 is referred
to as a follow-on biologic because of its regulatory pathway. In
other countries, MK-1293 is considered to be a biosimilar.
2 LANTUS is a registered trademark of Sanofi-Aventis, which is
not affiliated with the maker of MK-1293 and does not endorse
MK-1293.
3 In the U.S., follow-on insulins, such as MK-1293, are reviewed
under a different regulatory pathway than biosimilars, which follow
the 351(k) regulatory pathway.
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MerckMedia:Doris Li, 908-246-5701orKristen Drake,
908-236-4223orInvestors:Amy Klug, 908-740-1898
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