FDA Rejects Merck Surgery Drug, Again
According to the Pharmaceutical Market Group, the U.S. Food and Drug Administration has once again denied approval for Merck’s drug Bridion (sugammadex sodium).
FDA Concerned with Hypersensitivity Linked to Bridion
- The recent complete response letter (CRL) issued by the FDA marks the second time they have rejected Merck’s drug due to hypersensitivity concerns.
- Upon Merck’s first attempt to gain FDA approval, the FDA requested that the company run clinical trials to gather data on the risk of hypersensitivity the drug posed to patients.
- With the clinical trials now complete, Merck states that the CRL “raised concerns about operation aspects of the hypersensitivity study.”
- The FDA had conducted an inspection at the site of the hypersensitivity study and canceled a July advisory committee meeting with Merck as a result of their observations.
Bridion Being Used in 50 Other Countries
- Bridion is used to reverse the effects of muscle relaxants, like rocuronium and vecuronium, that are used during surgery.
- Merck also claims that the drug can aid patients in coming out of anesthesia quicker and with fewer side effects than other drugs.
- The drug is currently being used in 50 countries and has been available in Europe for 5 years.
- Though the drug pulled in $260 million for Merck last year, the company estimates that U.S. approval would result in a total of $500 million a year.
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