US FDA On Merck’s Chronic Cough Drug Gefapixant

Breaking News: Now the US FDA has raised concerns on Merck’s chronic cough drug Gefapixant. US health regulator has raised the concerns after Merck has officially submitted the additional efficacy data. Recently, the shares of Merck fell to around 1% at $101.2 in the afternoon trade. On the other hand, the FDA has raised concerns that data on Merck’s chronic drug Gerfapixant is not enough to prove the benefits of the drug. This has been recently claimed by the FDA. We know some of you are unaware of Gerfapixant. So in this article, we are going to tell you everything about this drug and we are going to share every single piece of detail about this topic. So read this article till the end.

US FDA

On 14th November 2023, Wednesday, the United States Food and Drug Administration (FDA) raised concerns that clearly show the data on Merck’s chronic cough drug “Gefapixant” is not enough to prove the benefits of the drug. The United States health regulator has raised the concerns after Merck officially submitted the additional efficacy data. This development came after a meeting of independent experts. The panel of experts is all set to meet on 17th November 2023, Friday to discuss the efficacy of Gefapixant.

In January 2022, the United States Food and Drug Administration officially declined to approve the drug. On the other side, the European Union and Japan approved the Merck drug for chronic cough which is sold under the brand name Lyfnua. Currently, there are no approved treatments for chronic cough in the US. The current condition is estimated to affect around 10% of the adult population in the entire world. As per the statement given by Merck, Gefapixant works as it blocks the receptors that stimulate the nerves and triggers the urge to cough.

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Merck shares have fallen to around 1% at $101.2 in the afternoon trade. on 30th September 2023, the quarter ended, the Merck & Co. reported higher than it was expected earnings on the very strong demand for COVID-19 treatment. The sales of molnupiravir, the COVID-19 antiviral pill sold under the brand name Lagevrio jumped 47% to $640 million in the quarter. The Merck company has raised the sales forecast for the drug. The sales of Merck’s top spelling cancer immunotherapy Keytruda in Q3 have stood at around $6.34 billion which officially surpassed the analysts. The company is expecting a sales range of around $59.7 billion to $60.2 billion which is up from the previous forecast of $58.6 billion to $59.6 billion.

Prakash Israni
Prakash Israni

Prakash, the content creator for Techballad, has built a solid reputation for himself over the course of more than ten years of blogging