Merck seeks first U.S. FDA authorization for COVID-19 tablet
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[October 11, 2021]
(Reuters) -Merck & Co Inc said on
Monday it has applied for U.S. emergency use authorization for its
tablet to treat mild-to-moderate patients of COVID-19, putting it on
course to become the first oral antiviral medication for the disease.
Its authorization could help change clinical management of COVID-19 as
the pill can be taken at home. The treatment, molnupiravir, could halve
the chances of death or being hospitalized for those most at risk of
contracting severe COVID-19, according to the drugmaker.
The interim efficacy data on the drug, which has been developed with
Ridgeback Biotherapeutics, had heavily impacted the shares of COVID-19
vaccine makers when it was released last week.
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Existing drugs from Gilead Sciences Inc's infused antiviral remdesivir
and generic steroid dexamethasone are generally given only once a
patient is hospitalized.
Monoclonal antibody drugs from Regeneron Pharmaceuticals Inc and Eli
Lilly have so far seen only limited use due to the difficulty in
administering them.
In India, however, two drugmakers had last week sought to end late-stage
trials of their generic versions of molnupiravir to treat moderate
COVID-19, according to study documents.
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The Merck logo is seen at a gate to the Merck & Co campus in Rahway,
New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid
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A source with the Drug Controller General of India
had said the pill has not shown "significant efficacy" against
moderate cases, but was successful against mild cases.
Merck said its trials are based on U.S. Food and Drug Administration
definitions, which for moderate COVID-19 describe blood oxygen
levels as no lower than 93% whereas the trials in India define
moderate as blood oxygen levels between 90% and 93%.
(Reporting by Manas Mishra and Leroy Leo in Bengaluru; Editing by
Arun Koyyur)
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