Molnupiravir manufacturer optimistic of securing Philippine regulatory approval this year

The manufacturer of oral antiviral drug molnupiravir is hoping to secure regulatory approval as a possible treatment for COVID-19 and release it to the public this year.

According to Dr. Mary Ann Galang-Escalona, country medical lead of MSD in the Philippines, the timeline would depend on the findings of the clinical trial and the interim analysis of the global team.

“We are hoping for that, we are all hoping for that… Hopefully this year,” she said in a virtual briefing.

Molnupiravir is developed by MSD, known as Merck & Co. in the United States and Canada, and Ridgeback Biotherapeutics LP. It plans to first secure an emergency use authorization (EUA) in the United States before rolling out in other countries.

“It will depend on the US EUA and the interim analysis that our global team is submitting to the US FDA (Food and Drug Administration),” Escalona said.

Escalona said the company is also working to secure approval from European regulators, and that data from the submissions will be brought into the Philippines for the application of an EUA in the country.

Should the drug score regulatory approval, Escalona said it would not be available over the counter and would need prior consultations with doctors before being prescribed.

Molnupiravir already entered its third phase of clinical trials at the Lung Center of the Philippines, with at least 15 patients already covered.

The Quirino Medical Memorial Center also just recently started, and is set to accept up to 10 patients for the clinical trial.

Lung Center Emergency Room and COVID-19 Triage Task Force chief Dr. Randy Castillo earlier said the drug has shown promise based on the initial results of the clinical trials.

“As to the moment the reason why we based it in NCR for two sites is because the highest burden of COVID would be in that particular area,” Escalona explained.

The Philippines has continued to record an increase in the tally of new confirmed COVID-19 cases in the last five days, with the active case count at 106,672 as of August 16.

The country reported 14,610 new cases on Monday, bringing the total caseload to  1,755,846. This includes 1,618,8008 recoveries, and 30,366 deaths.

Both hospitals are now seeking volunteers who would like to enter the clinical trials. Among those qualified are unvaccinated adults who have tested positive for COVID-19 and have had symptoms at least five days before entering the trial.

Those willing to join may contact the Lung Center of the Philippines at 09178999610 or the Quirino Memorial Medical Center at 09178413314. —KBK, GMA News