Gefapixant

The FDA has issued a complete response letter declining to approve a new drug application for gefapixant as a treatment for adults with refractory or unexplained chronic cough, according to a press release from Merck.

In November, all but one of the members of the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against recommending the approval of gefapixant for adults with refractory or unexplained chronic cough.

In a 12-to-1 vote, the FDA’s Pulmonary-Allergy Drug Advisory Committee voted against approving gefapixant 45 mg tablets to treat adults with refractory or unexplained chronic cough.

Gefapixant only showed small effects vs. placebo on objective cough frequency, cough severity and quality of life among adults with refractory or unexplained chronic cough, according to results of a systematic review and meta-analysis.

The FDA has issued a complete response letter declining to approve a new drug application for gefapixant to treat adults with refractory and unexplained chronic cough, according to a press release issued by Merck.

The Healio Editors compiled the most-read chronic cough news published in 2021.

A pooled analysis of the COUGH-1 and COUGH-2 trials demonstrated long-term efficacy of twice-daily gefapixant out to 52 weeks in patients with refractory or unexplained chronic cough, according to data presented at the CHEST Annual Meeting.

The Healio Editors have compiled a list of the most-read news in pulmonology posted in May.

This week, a monoclonal antibody cocktail cut COVID-19 hospitalization and death; removing race correction in lung function tests shows more severe disease in Black patients; gefapixant reduces chronic cough frequency in a large pooled analysis; and more.

Gefapixant 45 mg twice daily resulted in clinically important reductions in cough frequency compared with placebo in patients with refractory or unexplained chronic cough.