FDA still reviewing molnupiravir for EUA — DOH

The Food and Drug Administration is still reviewing the documents for the emergency use authorization of experimental anti-viral pill molnupiravir, the Department of Health said Monday.

“Sa ngayon po ang molnupiravir, pinagaaralan pa lang ng FDA ang kanilang submitted documents para magkaroon sila ng EUA dito sa ating bansa,” Health Undersecretary Maria Rosario Vergeire said during a media briefing.

(At present, the FDA is still looking into their submitted documents for them to get EUA in the country.)

According to Vergeire, 89 hospitals in the country are using molnupiravir through a compassionate special permit.

“While doing that, they have applied for a compassionate special permit. So meron na po tayo ngayon 89 hospitals using molnupiravir, including QualiMed hospitals and five pharmaceutical companies,” Vergeire said.

A clinical investigator from the Quirino Memorial Medical Center in Quezon City has said that molnupiravir is likely to be active against the Omicron variant, a new variant of concern.

Molnupiravir is shown to decrease by half the chances of mild cases from becoming severe as well as the chances of exposed individuals from acquiring the illness.

When asked if the government will procure Pfizer’s antiviral COVID-19 pill Paxlovid, Vergeire said it has yet to apply for EUA in the country.

“So inaantay lang din po natin ‘yan because as we always say, kahit walang CPR, as long as they apply and ma-evaluate, it can be cleared by the FDA, a compassionate special permit can be given,” she said.

(So we’re just waiting for this because as we always say, even without CPR, as long as they can be cleared by the FDA, a compassionate special permit can be given.)

“But we need to wait for applicants bago tayo makagamit nitong gamot na ito (before we can use this drug),” she added.

Pfizer said interim data from ongoing trials demonstrated an 89 percent reduction in the risk of COVID-19-related hospitalization or death compared to a placebo, in non-hospitalized high-risk adults with COVID-19 within three days of symptom onset.

Similar results were seen within five days of symptom onset, it added. — RSJ, GMA News