USFDA declines to approve Merck chronic cough drug Gefapixant
New Jersey: 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.
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