FDA asked to clear COVID-19 antiviral pill molnupiravir for EUA in Philippines

MANILA, Philippines (Updated Nov. 19, 2021, 12:08 p.m.) — A local distributor has sought for emergency use authorization of the COVID-19 antiviral pill Molnupiravir in the Philippines, the Food and Drug Administration has said.

FDA chief Eric Domingo had told ANC’s “Headstart” on November 18 that pharmaceutical company Merck & Co. had applied for the EUA.

He has since clarified that it was Faberco Life Sciences Inc. that submitted the application and would be its distributor.

"This is now under evaluation," he said over ANC in mixed English and Filipino. "Although our experts still have questions to the applicant that need to be answered."
Molnupiravir is an investigational oral antiviral drug. The World Health Organization, citing interim phase III clinical trials, said it reduces the risk of hospitalization among mild to moderate COVID-19 cases by 50%. 

As of end-October, molnupiravir is being evaluated by the WHO for a possible inclusion in its list of approved COVID-19 therapeutics. 

Domingo said while supplies of the pill are already in the Philippines, its access remains limited in hospitals with compassionate special permit from the FDA. 

Apart from molnupiravir, he added the agency had already issued an EUA to ronapreve for treatment COVID-19 cases. 

The FDA chief said the drug is for mild to moderate coronavirus infections, and can be taken by individuals 12 years old and above. 

And as the Philippines begins administering COVID-19 booster shots starting with health workers, Domingo stressed getting the jabs on the unvaccinated remains a priority. 

"Before we give extra doses, it's really more important for more people in the population to get the vaccines," he said. "These are available in your respective local government units so please have yourself listed as soon as you can."

Editor’s note: This story, first published on Nov. 18, 2021, was updated to clarify that Merck & Co. did not apply for the EUA in the Philippines but Faberco Life Sciences Inc.