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Sugammadex Faces Third FDA Rejection

Treatment reverses neuromuscular blockade

The FDA has cancelled a meeting of its Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, 2015. The committee had planned to discuss the resubmission of a new drug application (NDA) for sugammadex sodium injection (Merck), an investigational medication for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Neuromuscular blockade is used in anesthesiology to induce muscle relaxation during surgery. Sugammadex is designed to work by directly inactivating rocuronium or vecuronium, two neuromuscular blocking agents, via encapsulation. If approved, sugammadex would be the first in a new class of medications, known as selective relaxant binding agents, to be used in the U.S. It is currently marketed in more than 50 other countries.

The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101). The agency indicated that it plans to conduct these additional inspections prior to an advisory committee meeting and completion of their review.

Because of the timing of the additional inspections, Merck expects to receive a complete response letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015.

In 2008, the FDA did not approve the original NDA for sugammadex sodium injection, requesting additional data related to hypersensitivity reactions and coagulation events. Merck provided these data in an NDA resubmission in January 2013, and the FDA rejected this resubmission in September. Merck submitted the NDA for a third time in November 2014.

Sources: Merck; March 13, 2015; Merck; November 24, 2014; Merck; September 23, 2013; and Merck; January 7, 2013.

 

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