Merck Receives Complete Response Letter for Investigational Medicine
Sugammadex Sodium Injection
WHITEHOUSE STATION, N.J. -- September 23, 2013
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced
today that the company has received a Complete Response Letter from the U.S.
Food and Drug Administration (FDA) for the resubmission of the New Drug
Application for sugammadex sodium injection, Merck’s investigational medicine
for the reversal of neuromuscular blockade induced by rocuronium or
The FDA’s letter raised concerns about operational aspects of a
hypersensitivity study that the agency had requested in 2008. Merck is
evaluating the Complete Response Letter and expects to be able to determine a
path forward in the very near future.
“We believe sugammadex is an important innovation, and will work closely with
the FDA to bring this product to hospitals, surgeons, anesthesia professionals
and patients in the United States,” said David Michelson, M.D., head of global
neuroscience clinical development, Merck Research Laboratories.
As previously disclosed, the FDA cancelled the discussion of sugammadex at the
July 18th Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).
At that time, the FDA advised Merck that the agency needed additional time to
assess the results of the agency’s recently completed inspection of a clinical
trial site conducting the hypersensitivity study.
Neuromuscular blockade is used in anesthesiology to induce muscle relaxation
during surgery. Sugammadex is designed to work by inactivating rocuronium or
vecuronium, two neuromuscular blocking agents, directly by encapsulation. If
approved, sugammadex would be the first in a new class of medicines, known as
selective relaxant binding agents, to be used in the U.S. Sugammadex is
currently marketed in more than 50 countries other than the U.S., and more
than 5 million vials have been sold as of June 2013.
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