Pfizer’s anti-COVID-19 pill, Merck’s molnupiravir to be available if they seek approval –DOH

Pfizer’s anti-COVID-19 pill and Merck & Co’s experimental antiviral pill molnupiravir can be made available locally if the manufacturers of the drugs apply and hurdle regulatory processes in the Philippines.

“If manufacturers apply for regulatory clearance and FDA (Food and Drug Administration) approves based on safety and quality, yes it will be made available,” Health Undersecretary Maria Rosario Vergeire said in a text message on Saturday.

For his part, FDA Director-General Eric Domingo said the antiviral drugs can be made available in the country “via compassionate special permit (CSP).”

“The doctors and hospitals can apply for CSP,” Domingo said.

On Monday, Pfizer said it had begun a middle-to-late stage clinical trial of a pill to stave off COVID-19 in people who are exposed to infection.

Pfizer started developing its drug, called PF-07321332, in March 2020 and is testing it in combination with ritonavir, a repurposed HIV medicine.

The clinical trial will enroll 2,660 adults who will take part at the first sign of COVID-19 infection or first awareness of exposure.

They will be randomly assigned to receive either a combination of PF-07321332 and ritonavir, or a placebo twice a day for five or ten days.

The objective is to assess the safety and efficacy of the drugs being studied at preventing SARS-CoV-2 infection and symptomatic disease by day 14.

Meanwhile, Merck’s molnupiravir could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.

If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

Merck and partner Ridgeback Biotherapeutics said they plan to seek US emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide. — DVM, GMA News