FDA grants ‘compassionate’ permit for molnupiravir for use vs Covid-19


Food and Drug Administration (FDA) Director-General

Eric Domingo on Wednesday said four hospitals have been granted Compassionate Special Permit (CSP) as of Tuesday for anti-viral drug molnupiravir believed to be effective against Covid-19.

In a televised Laging Handa briefing, Domingo said the Philippines is included in the multi-country clinical trial of the molnupiravir.

In the interim analysis, it was seen that it can prevent possibly 50 percent of people going into severe covid and dying from covid. So, it’s promising,” he added in Filipino.

Molnupiravir was developed by Merck & Co. which explained it is likely to be effective against all known coronavirus variants as it does not target the spike protein of the virus that differentiates the variants.

The pharmaceutical company has not applied for the emergency use authorization (EUA) in the country, but it is soon to apply for one in the United States.

Despite the absence of the EUA, as an investigational drug, it can apply for CSP in the Philippines,” Domingo said in Filipino.

He noted the clinical trial of the drug in the country must continue even if it is granted EUA by the US FDA as the authorization is provided based on “early partial results of the clinical trial”.

On Monday, Health Undersecretary Maria Rosario Vergeire cited an ongoing clinical trial of the drug at the Lung Center of the Philippines (LCP).

In August, the LCP and the Quirino Memorial Medical Center asked the public for Covid-19 patients who are interested to be a part of Phase 3 clinical trials of molnupiravir.

The FDA has not named the other hospitals granted the CSP for molnupiravir.

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