US FDA staff flags concerns on Merck’s chronic cough drug
2023.11.15 12:43
© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
(Reuters) -The U.S. Food and Drug Administration’s reviewers on Wednesday flagged concerns that data on Merck’s chronic cough drug might not be sufficient enough to prove the treatment’s meaningful benefit, documents released ahead of their meeting this week showed.
The concerns were raised after the company submitted additional data to the regulator, which had declined to approve the drug in January last year.
A panel of the FDA’s independent experts are set to meet on Friday to discuss the efficacy of the drug, gefapixant, for which the company is seeking approval to treat unmanageable or unexplained cough in adults.
Currently, there are no approved therapies for chronic cough in the United States. The condition is estimated to affect about 10% of the adult population globally and roughly half of those patients do not have an identifiable cause behind their cough despite diagnostic tests.
