FDA Expert Panel to , Determine the Efficacy of , Merck's Chronic Cough Medication.
FDA Expert Panel to , Determine the Efficacy of , Merck's Chronic Cough Medication.
On November 15, health regulators in the
United States flagged concerns that Merck's chronic
cough drug, gefapixant, may not have a meaningful benefit.
On November 15, health regulators in the
United States flagged concerns that Merck's chronic
cough drug, gefapixant, may not have a meaningful benefit.
Reuters reports that the concerns
were listed in documents released ahead
of a meeting of independent experts.
In afternoon trading, Merck shares
were down almost 1%, coming in at $101.2. .
Concerns were raised after additional efficacy
data was submitted by the company to the
U.S. Food and Drug Administration (FDA).
Concerns were raised after additional efficacy
data was submitted by the company to the
U.S. Food and Drug Administration (FDA).
In January of last year, the FDA
declined to approve the drug.
The FDA's expert panel of advisers is set to meet
on November 17 to discuss the data provided by
Merck and determine the efficacy of gefapixant.
Reuters reports that the panel will determine whether the
small reduction in cough frequency that comes with the
drug is clinically meaningful enough to be approved.
Reuters reports that the panel will determine whether the
small reduction in cough frequency that comes with the
drug is clinically meaningful enough to be approved.
Chronic cough impacts about 10% of the world's adult
population, with about half of those individuals not having
an identifiable cause for the cough despite testing. .
Merck's gefapixant blocks receptors that
stimulate nerves which trigger a cough.
In the European Union and Japan, the drug
has been approved to treat chronic coughing
and is sold under the brand name Lyfnua