USFDA approval granted for this chronic cough drug

These concerns emerged Merck's submission of additional data to the USFDA, which had previously declined USFDA approval for the drug in January last year.

USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

USFDA approval

The U.S. health regulator’s staff recently expressed reservations regarding the data supporting the efficacy of Merck’s chronic cough drug, gefapixant.

These concerns emerged following Merck’s submission of additional data to the U.S. Food and Drug Administration (USFDA), which had previously declined approval for the drug in January last year.

In this article, we explore the intricacies of this situation and the upcoming USFDA panel meeting that aims to evaluate the drug’s effectiveness.

Background on Merck’s Drug – Gefapixant

Gefapixant, designed to alleviate chronic cough, operates by blocking receptors that stimulate nerves, thus mitigating the urge to cough. Its unique mechanism sets it apart in the realm of cough therapies.

USFDA’s Initial Rejection

The USFDA’s initial rejection of gefapixant marked a pivotal moment for Merck. It prompted the company to reevaluate and strengthen its case by submitting additional efficacy data.

Additional Data Submission

Merck’s decision to provide supplementary data underscores its commitment to addressing the USFDA’s concerns. However, questions linger about the sufficiency of this data in establishing the drug’s meaningful benefit.

Upcoming USFDA Panel Meeting

A panel of expert advisers is scheduled to convene to discuss the efficacy of gefapixant. This meeting holds the key to determining whether the data submitted by Merck convincingly demonstrates the drug’s clinical significance in reducing cough frequency.

Clinical Significance of Cough Reduction

The central question revolves around whether a marginal reduction in cough frequency is meaningful to patients suffering from chronic cough. The panel’s deliberations will shed light on this critical aspect.

Prevalence of Chronic Cough

Chronic cough is a pervasive issue, affecting approximately 10% of the adult population globally. Alarmingly, half of these patients lack a discernible cause for their cough, despite undergoing diagnostic tests.

Diagnostic Challenges

The challenge in identifying the root cause of chronic cough adds a layer of complexity to the quest for effective therapies. The absence of approved treatments in the U.S. accentuates the urgency of finding a solution.

Mechanism of Gefapixant

Gefapixant’s method of action, blocking receptors that trigger the cough reflex, positions it as a potential breakthrough in treating chronic cough. Understanding this mechanism is crucial to appreciating the drug’s potential.

Results from Late-Stage Trials

Two late-stage trials showcased promising results for gefapixant. The higher dosage demonstrated a statistically significant reduction in the average number of coughs per hour over a 24-hour period compared to a placebo.

Global Approval Status

While the USFDA deliberates, it’s noteworthy that the European Union and Japan have already given their approval to Merck’s drug, marketing it under the brand name Lyfnua.

USFDA’s Concerns: Analyzing Data Adequacy

The USFDA’s expressed concerns about data adequacy warrant closer scrutiny. Examining the specifics of these concerns will provide insight into the potential roadblocks faced by Merck.

Comparison with Approved Therapies

In the absence of approved therapies for chronic cough in the U.S., a brief comparison with existing treatments can highlight gefapixant’s potential advantages or limitations.

Industry Implications

The USFDA’s decision regarding gefapixant carries broader implications for Merck and the pharmaceutical industry at large. Understanding these ramifications adds depth to the ongoing narrative.


  1. What is gefapixant, and how does it work?
    • Gefapixant is a drug designed to alleviate chronic cough by blocking receptors that stimulate nerves, reducing the urge to cough.
  2. Why did the USFDA initially reject Merck’s drug?
    • The USFDA declined approval in January last year, prompting Merck to submit additional efficacy data to address concerns.
  3. How prevalent is chronic cough, and why is it challenging to diagnose?
    • Chronic cough affects around 10% of the global adult population, and diagnostic challenges arise as nearly half of patients lack a discernible cause.
  4. What were the results of gefapixant’s late-stage trials?
    • The trials demonstrated a statistically significant reduction in cough frequency with a higher dose compared to a placebo.
  5. What are the potential industry implications of the USFDA’s decision on gefapixant?
    • The decision may not only impact Merck but also influence the future of therapies for chronic cough, shaping the pharmaceutical landscape.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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