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Merck seeks first US authorization for COVID-19 tablet

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Merck seeks first US authorization for COVID-19 tablet

An authorization from the US Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home.

By REUTERS
 

OCTOBER 11, 2021 15: 49

Early Newspaper

 The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, US, July 12, 2018.  (photo credit: REUTERS/BRENDAN MCDERMID)

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, US, July 12, 2018.

(photo credit: REUTERS/BRENDAN MCDERMID)

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.

An authorization from the US Food and Drug Administration could help change clinical management of COVID-19 as the pill can be taken at home.


— Merck (@Merck) October 11, 2021

The treatment, molnupiravir, cut the rate of hospitalization and death by 50% in a trial of mild-to-moderately ill patients who had at least one risk factor for the disease, according to data released earlier this month.

The interim efficacy data on the drug, developed with Ridgeback Biotherapeutics, had heavily dented the shares of COVID-19 vaccine makers and set off a scramble among nations, including Malaysia, South Korea and Singapore, to sign a supply deal with Merck.

 An experimental COVID-19 treatment pill called molnupiravir being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters May 17, 2021. (credit: MERCK & CO INC/HANDOUT VIA REUTERS) An experimental COVID-19 treatment pill called molnupiravir being developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters May 17, 2021. (credit: MERCK & CO INC/HANDOUT VIA REUTERS)

The drugmaker has a US government contract to supply 1.7 million courses at a price of $700 per course. Merck expects to produce 10 million courses of the treatment by the end of 2021.

It has also agreed to license the drug to several India-based generic drugmakers, which are expected to supply the treatment to more than 100 low- and middle-income countries.

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, which are typically infused as well, have so far seen only limited use due to the difficulty in administering them.

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Merck seeks first US authorization for COVID-19 tablet