The US Food and Drug Administration (FDA) expressed concern on Wednesday that data on Merck’s chronic cough drug gefapixant may not be enough to prove the drug’s benefit.
The US healthcare regulator raised these concerns after Merck submitted additional efficacy data.
The development takes place prior to a meeting of independent experts.
A panel of experts will meet on Friday to discuss the efficacy of gefapixant.
In January last year, the US FDA had refused to approve the drug.
However, the European Union and Japan have approved Merck’s drug for chronic cough and it is sold under the brand name Lyfnua.
Currently, there are no approved treatments for chronic cough in the United States. It is estimated that the condition affects approximately 10% of the adult population worldwide.
According to Merck, gefapixant works by blocking receptors that stimulate the nerves and cause the urge to cough.
Merck shares fell nearly 1% to $101.2 in afternoon trading.
For the third quarter ended September 30, 2023, Merck & Co had reported higher-than-expected profits thanks to surprisingly strong demand for its Covid-19 treatment, mainly in Japan.
Sales of molnupiravir, the Covid-19 antiviral pill sold under the brand name Lagevrio, rose 47% in the quarter to $640 million.
Merck had also raised its sales forecast for the drug.
Sales of Merck’s top-selling cancer immunotherapy Keytruda reached $6.34 billion in the third quarter, beating analysts’ average estimate.
Merck now expects 2023 sales of $59.7 billion to $60.2 billion, up from its previous forecast of $58.6 billion to $59.6 billion.
In its latest quarter, the company said it had already booked most of the 2023 revenue it expected for Lagevrio in the first half of the year, so the increase comes as a surprise.
Merck had reported revenue of $15.96 billion in the reported quarter.
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Updated: Nov 16, 2023 00:58 IST