US FDA raises concerns on Merck’s chronic cough drug gefapixant

The US Food and Drug Administration (FDA) on Wednesday raised concerns that data on Merck’s chronic cough drug gefapixant may not be enough to prove the drug’s benefit.

The US health regulator raised the concerns after Merck had submitted additional efficacy data.

The development comes ahead of a meeting of independent experts. 

A panel of experts is set to meet on Friday to discuss the efficacy of gefapixant.

In January last year, the US FDA had declined to approve the drug.

However, the European Union and Japan have approved Merck’s drug for the chronic cough and is sold under brand name Lyfnua.

Presently, there are no approved treatments for chronic cough in the United States. The condition is estimated to affect about 10% of the adult population globally.

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

Shares of Merck fell nearly 1% at $101.2 in afternoon trade. 

For the third quarter ended September 30 2023, Merck & Co had reported higher-than-expected earnings on surprisingly strong demand for its Covid-19 treatment, primarily in Japan.

Sales of molnupiravir, the Covid-19 antiviral pill sold under brand name Lagevrio, jumped 47% to $640 million in the quarter.

Merck had also raised its sales forecast for the drug.

Sales of Merck’s top-selling cancer immunotherapy Keytruda in the third quarter stood at $6.34 billion, surpassing analysts’ average estimate.

Merck now expects 2023 sales in the range of $59.7 billion to $60.2 billion, up from its previous forecast of $58.6 billion to $59.6 billion.

In the last quarter, the company said it had already booked most of the 2023 sales it expected for Lagevrio in the first half of the year, so the increase comes as a surprise.

Merck had reported sales of $15.96 billion in the reported quarter.

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Updated: 16 Nov 2023, 12:58 AM IST

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