Merck & Co Inc (MSD) has applied for emergency use authorization (EUA) in the Philippines for Molnupiravir, its antiviral medicine and investigational COVID-19 drug, Food and Drug Administration (FDA) Director-General Eric Domingo said on Thursday.
Domingo said the American firm’s application, filed last week, is being evaluated.
The COVID-19 antiviral drug is not commercially available yet in the country, but i31 hospitals that have a compassionate use special permit for it, Domingo said.
The initial shipment of the drug arrived in the Philippines on Thursday, pharmaceutical firm Faberco Life Sciences Inc. confirmed.
Merck earlier said it was expecting to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.
The FDA approved the emergency use of COVID-19 treatment drug Ronapreve in October, the first to get such a grant locally.
It is also called Regen-Cov in the United States, manufactured by Roche.
In a statement, Faberco Life Sciences said it was appointed to distribute Molnupiravir in the Philippines by one of Merck's manufacturing licenses.
Molnupiravir cuts the rate of hospitalization and death by 50 percent in a trial of mild-to-moderately ill COVID-19 patients who had at least one risk factor for the disease, according to data released earlier this month.
The pill would be the world's first oral antiviral medication for COVID-19 if it gets regulatory approval.
The pill, which is estimated to cost P100 to P150, is an investigational drug used for COVID-19 treatment.
Faberco said they chose RiteMed Philippines, Inc. to distribute the investigational drug to private hospitals and medical institutions that have secured a compassionate use permit from the FDA.