Merck said on Monday that it has sought for emergency use authorization in the United States for its tablet to treat mild-to-moderate COVID-19 patients, putting it on track to become the disease's first oral antiviral medicine.
Because the pill can be administered at home, its approval could assist the clinical care of COVID-19. According to the drugmaker, the medicine, molnupiravir, could cut the risk of mortality or hospitalization in people most at risk of getting severe COVID-19 by half.
When interim efficacy data on the medicine, which was developed with Ridgeback Biotherapeutics, was disclosed last week, it had a big influence on COVID-19 vaccine producers' stock.
Existing antiviral remdesivir and generic steroid dexamethasone from Gilead Sciences are usually only provided once a patient is admitted to the hospital.
Due to the difficulty in administering monoclonal antibody medications from Regeneron Pharmaceuticals and Eli Lilly, they have only seen limited use thus far.
According to research paperwork, two drugmakers in India wanted to stop late-stage trials of their generic versions of molnupiravir to treat mild COVID-19 last week.
According to a source from India's Drug Controller General, the pill did not show "substantial efficacy" against moderate cases but was effective against light cases.
Merck claims that their trials are based on FDA guidelines, which define moderate COVID-19 as blood oxygen levels of no less than 93 percent, whereas the trials in India define moderate as blood oxygen levels of 90 percent to 93 percent.