Merck Receives Complete Response Letter for Investigational Medicine Sugammadex Sodium Injection
September 23, 2013 7:00 am ET
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 vecuronium.
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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