Merck unit seeks Japan's approval of oral COVID drug

Kyodo News

Posted at Dec 03 2021 06:18 PM

The Japanese arm of US pharmaceutical giant Merck & Co. said Friday it has applied for state approval for the production and sale of an oral COVID-19 drug, which if granted could be the first such pill to be used in Japan.

MSD K.K. said in a press release that it is seeking the green light from the Ministry of Health, Labor and Welfare under a fast-track process for the Merck-developed molnupiravir, which prevents the virus from entering or multiplying in the body.

The Japanese government has already agreed with Merck on the procurement of 1.6 million doses and plans to make the orally-administered pill available by the end of the year. The drug, which can be taken at home, is regarded by Japan as vital to fighting the pandemic.

Clinical trial data show that patients given the drug within five days of developing coronavirus symptoms were 30 percent less likely to be hospitalized or die compared to those who were given a placebo, according to the Japanese subsidiary.

In an interim report on clinical trials across areas including Japan, Europe and the United States, Merck initially reported that the use of the oral drug halves the risk of hospitalization and death. But the percentage was revised downward after the firm increased the number of trial participants.

The United States, where approval of molnupiravir is currently being processed, is expected to allow the emergency use of the oral medicine for COVID-19 adult patients who are at risk of developing severe symptoms.

Britain on Nov. 4 became the first country in the world to approve use when it gave the green light for prescribing molnupiravir for people with mild or moderate symptoms and at least one risk factor for developing severe illness.

The British regulator does not recommend the use of the drug for pregnant people. The drug is not approved for children.

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