Merck & Co., has received a Complete Response Letter from FDA for the resubmission of its 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 the 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 near future.
As previously disclosed, the FDA cancelled the discussion of sugammadex at the July 18th Anesthetic and Analgesic Drug Products Advisory Committee. 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.
Sugammadex is currently marketed in more than 50 countries other than the United States. If approved, sugammadex would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the US.
Source: Merck & Co.