FDA allows emergency use of COVID pill molnupiravir
The country’s health regulatory agency has allowed the emergency use of the COVID-19 treatment pill molnupiravir.
The Food and Drug Administration (FDA) granted the application for emergency use authorization (EUA) of Molnarz’s molnupiravir, a licensee of pharmaceutical company MSD or Merck & Co.
The EUA allows wider use of molnupiravir on people infected with the coronavirus. Previously, under a compassionate use permit, it could be used only in select health facilities. According to FDA Director General Eric Domingo, the molnupiravir pill comes in 200-milligram capsules and can be given to patients with mild and moderate COVID-19.
At Thursday’s Laging Handa briefing, Domingo said the pill could be given only to adults 18 years old and above who were found positive for COVID-19 and with risk factors for developing severe illness, such as senior citizens and those with comorbidities.
He said it could not be given to those with severe symptoms or those with low oxygen level, as well as pregnant and lactating women.
“We do not have enough data to say that it would be safe for this group of patients,” Domingo said.
Molnupiravir would be given in dosages of 800 mg twice a day for five days.
Patients must take the drug as soon as possible after diagnosis, and within the first five days after the onset of symptoms or “it would not be very useful,” he said.
“It can’t be given to patients with severe illness because it would not help,” Domingo added.
In November, Merck said the molnupiravir pill, which it developed with Ridgeback Biotherapeutics, showed a 30-percent reduction in hospitalizations and deaths, lower than the 50-percent efficacy indicated by earlier data.
The updated data, Merck said, came from a study involving 1,433 COVID-19 patients.
In October, Merck said its data showed a 50-percent efficacy, based on data from 775 patients.
In the same month, the Philippine FDA granted several hospitals a compassionate special permit for the use of molnupiravir.
A five-day molnupiravir treatment reportedly costs about $700 in the United States.
The antiviral medication introduces “copying errors” into the genetic code of the virus during RNA replication, making the virus harmless. This prevents the deadly growth and spread of COVID-19 in the body. —with a report from Inquirer Research
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