Merck receives Complete Response Letter from FDA for sugammadex

US pharma major Merck & Co (NYSE: MRK) has received a Complete Response Letter from the US 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, which is known as MSD outside the USA and Canada, is evaluating the Complete Response Letter and expects to be able to determine a path forward in the very near future.

David Michelson, head of global neuroscience clinical development, Merck Research Laboratories, said: “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.”