Tag Archive for: gefapixant

The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.

The U.S. health regulator’s staff flagged concerns that data on Merck’s chronic cough drug might not be enough to prove the treatment’s meaningful benefit, documents released ahead of a meeting of independent experts showed.

Tuesday, GSK signed an acquisition agreement with Bellus Health for $2 billion to gain access to the Canadian biotech’s chronic cough candidate camlipixant.

Merck’s exceptional revenue growth in 2021 and the first half of 2022 came thanks to three big brands, one of which is not even approved by the FDA yet.