MSD’s sugammadex knocked back by FDA – again
pharmafile | September 25, 2013 | News story | Research and Development, Sales and Marketing | FDA, MSD, Merck, Sugammedex
MSD says it has received a ‘complete response letter’ from the FDA for the resubmission of its troubled muscle relaxant drug sugammadex.
The drug, designed to reverse the effects of muscle relaxants used by anaesthesiologists during surgery, has caused concern with the US regulator, specifically related to a hypersensitivity study that the agency requested in 2008.
MSD, known as Merck in the US, said it 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, anaesthesia professionals and patients in the United States,” said David Michelson, head of global neuroscience clinical development, Merck Research Laboratories.
As previously disclosed by the firm, the FDA cancelled the discussion of sugammadex at the July 18th Anaesthetic 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 anaesthesiology 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 US. Sugammadex is currently marketed in more than 50 countries other than the US, and more than 5 million vials have been sold as of June 2013.
But despite the setback, BMO Capital Markets analyst Alex Arfaei said in a research note: “The FDA concerns in the complete response letter do not seem related to the product’s clinical profile. We expect the issues to eventually be resolved.”
Arfaei added that he expects US approval of sugammadex by the second quarter of 2014 and forecast worldwide sales of $574 million in 2015.
Ben Adams
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