Merck Statement on FDA Advisory Committee Meeting for BRIDION® (sugammadex), Investigational Agent for the Reversal of Neuromuscular Blockade (NMB) Induced by Rocuronium or Vecuronium
November 6, 2015 2:13 pm ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today issued the following statement after the conclusion of a meeting
of the Anesthetic and Analgesic Drug Products Advisory Committee of the
U.S. Food and Drug Administration (FDA) to discuss BRIDION®
(sugammadex). BRIDION is the proposed trade name for Merck’s
investigational agent for the reversal of neuromuscular blockade (NMB)
induced by rocuronium or vecuronium.
“We believe that BRIDION has the potential to offer anesthesia
professionals an important new option to reverse neuromuscular blockade
in the surgical setting,” said Dr. David Michelson, head of global
clinical development for neuroscience, Merck Research Laboratories.
“Today’s discussion is one step in the regulatory process, and we look
forward to working with the FDA as it completes the review of our New
Drug Application for BRIDION.”
The FDA is not bound by the committee’s guidance but takes its advice
into consideration when reviewing investigational medicines. The
Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review
of BRIDION is Dec. 19, 2015.
If approved, BRIDION would be the first in a new class of medicines,
known as selective relaxant binding agents, to be used in the U.S.
Today’s Merck is 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,
and connect with us on Twitter,
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the United States 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 healthcare legislation in the
United States and internationally; global trends toward healthcare 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 2014 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).
Pamela Eisele, 267-305-3558
Doris Li, 908-740-1903
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879