Monday, October 25

Merck seeks first US FDA authorization for COVID-19 tablet

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Merck & Co Inc said on Monday it has applied for US 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.

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Viral sequencing done so far have showed it is effective against all coronavirus variants, including Delta, Merck said.

The interim efficacy data on the drug, which has been developed with Ridgeback Biotherapeutics, had heavily impacted the shares of COVID-19 vacine makers when it was released last week.

Existing drugs include Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.

Meanwhile, monoclonal antibody drugs from Regeneron Pharmaceuticals Inc and Eli Lilly have so far seen only limited uptake due to the difficulty in administering them.

(Reporting by Manas Mishra and Leroy Leo in Bengaluru; Editing by Arun Koyyur)

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