PH awaits complete clinical trial results of Molnupiravir

MANILA – The Philippine government is closely monitoring the clinical trial of Molnupiravir, an investigational drug that is slated to be the first oral antiviral medication for the coronavirus disease 2019 (Covid-19).

“Malaking tulong ‘yan kapag nagtuloy-tuloy na ‘yung trial at nakapagpakita sa final result niya na talagang makakatulong sa mga pasyente (That would be a big help once findings show that it is effective for the patients),” Health Undersecretary Maria Rosario said in a Laging Handa briefing on Saturday.

There is no clinical trial of Molnupiravir in the Philippines but Vergeire said the government has been open to using investigational drugs, so long as there is evidence to prove its safety and efficacy.

She added that the Covid-19 Living Clinical Practice Guidelines (CPG) task force, led by various experts and key public health stakeholders, regularly studies potential Covid-19 drugs to make sure the Philippines and manufacturers could immediately negotiate once official results are out.

“(As for Molnupiravir), nasa trial stages pa rin itong gamot na ito so hintayin natin na makumpleto sila at officially ma-publish ‘yong results (this drug is still on trial stages so we will wait once the official results have been published),” Vergeire said.

Molnupiravir, an oral pill developed by Merck and Ridgeback Biotherapeutics, is designed to prevent the replication of several RNA viruses, including the SARS-CoV-2 virus that causes Covid-19.

Merck said the drug had significantly reduced by about 50 percent the risk of hospitalization or death among Covid-19-positive individuals who joined its late-stage trial.

An analysis of data from 775 patients enrolled in the trial found that only 7.3 percent of patients who received Molnupiravir were either hospitalized or died compared to 14.1 percent of placebo-treated patients.

“Through Day 29, no deaths were reported in patients who received Molnupiravir, as compared to eight deaths in patients who received placebo,” Merck said.

The pharmaceutical company said it now plans to submit an application for emergency use authorization to the United States Food and Drug Administration, as well as other regulatory bodies outside of the US.

It has also entered into non-exclusive voluntary licensing agreements with established generic manufacturers to accelerate the pill’s availability in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.