Merck seeks first U.S. FDA authorization for COVID-19 tablet

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.

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 the clinical management of COVID-19 as the pill can be taken at home. The treatment, molnupiravir, could halve the chances of death or be hospitalized for those most at risk of contracting severe COVID-19, according to the drugmaker.

Viral sequencing done so far has shown 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 vaccine makers when it was released last week.

Existing drugs include Gilead Sciences Inc's infused antiviral redeliver 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.

 

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