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Japan expects to approve Merck's COVID pill in December

First oral medication expected to work on omicron variant

Merck's pill molnupiravir has been shown in trials to reduce deaths and hospitalizations by 30% among mild to moderate cases of COVID-19.   © Reuters

TOKYO -- Japan plans to approve Merck's coronavirus pill for sale by the end of this month through an expedited process for priority drug candidates, the regulators said Friday.

The Japanese arm of the U.S. drugmaker, MSD, applied the same day to the health ministry to manufacture and market the oral medication, molnupiravir.

"We aim for an approval by year's end, and the priority screening will be conducted swiftly by the Pharmaceuticals and Medical Devices Agency," Chief Cabinet Secretary Hirokazu Matsuno told reporters.

If approved, molnupiravir would be the first oral medication available in Japan to treat mild to moderate cases of COVID-19.

Merck and U.S. peer Ridgeback Biotherapeutics developed molnupiravir as an antiviral drug. The pill acts to suppress the replication of coronavirus in the body.

Japan already has signed a roughly $1.2 billion contract for 1.6 million doses of the drug.

If approved, the first 200,000 doses will be distributed to hospitals and clinics this month, and another 400,000 by March 31.

The health ministry previously approved antibody treatments developed by Japan's Chugai Pharmaceutical and British drugmaker GlaxoSmithKline to treat mild to moderate cases of COVID-19. But both options are administered intravenously or by injections. Merck's pill can be taken at home, removing the need for hospital visits.

During clinical trials, molnupiravir was shown to reduce hospitalization and deaths by 30% among patients with mild to moderate symptoms who are at risk of developing severe symptoms. The treatment regimen involves two doses a day over five days.

MSD said the drug is expected to be effective against the omicron variant of the coronavirus as well.

The U.K. became the first country to approve molnupiravir on Nov. 4. The European Union later that month recommended emergency use of the drug for member states.

An advisory panel for the U.S. Food and Drug Administration on Tuesday recommended molnupiravir to treat adults with high risk of developing severe COVID symptoms. The FDA will base a decision to approve the drug on the panel's endorsement.

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