Tag Archive for: chronic cough

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.