US FDA declines to approve Merck's chronic cough drug

[December 21, 2023]  (Reuters) -The U.S. Food and Drug Administration (FDA) declined to approve Merck's drug for chronic cough, the company said on Wednesday, marking the second rejection in less than two years.

The health regulator concluded the company's application for the drug, gefapixant, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough.

Currently, there are no approved treatments in the United States for coughing bouts that don't go away despite treatment of underlying conditions or have no identifiable cause.

The condition is estimated to affect up to 13% of the global adult population.

In November, the agency's advisory committee panel voted 12 to 1 against the late-stage data submitted for gefapixant, on concerns over how well it works.

The FDA's decision was not related to the drug's safety, Merck said, adding that it is reviewing the agency's feedback to determine next steps.

Failing to secure marketing approval the first time, Merck carried out additional efficacy analyses of the drug to address questions raised by the health regulator. The results from the additional analyses were generally consistent with those from the late-stage trial, Merck said.

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo

The FDA's decision gives some breathing room to rival GSK's chronic cough treatment camlipixant, which is in late-stage development with anticipated regulatory approval and launch in 2026.

Merck's gefapixant works by blocking receptors that stimulate the nerves and trigger the urge to cough.

The drug, which was given twice a day, was evaluated across two late-stage trials where a higher dose showed statistically significant reduction in the average number of coughs per hour over a 24-hour period compared to a placebo, according to Merck.

The European Union and Japan have approved Merck's drug for the condition and it is sold under the brand name Lyfnua.

(Reporting by Christy Santhosh, Khushi Mandowara and Sriparna Roy in Bengaluru; Editing by Tasim Zahid and Shounak Dasgupta)

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