MANILA, Philippines — The Philippines’ drug regulator has given the first emergency use authorization for an anti-COVID pill, allowing wider use of the drug that was previously only available through select health facilities.
Food and Drug Administration director general Eric Domingo said Thursday on state-run People’s Television that it has granted emergency use authorization for Molnarz, a brand of the antiviral molnupiravir.
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Domingo said the drug is indicated for adults aged 18 and above with mild to moderate COVID-19 who have risk factors for developing severe illness.
It is to be taken twice a day for five days and should be given as soon as possible after diagnosis and within the first five days since the onset of symptoms, Domingo said.
He added that the oral pill is not recommended for pregnant women, those who may become pregnant and lactating women as it is not yet known whether the drug is safe for them.
Prior to this regulatory approval, hospitals have been using molnupiravir on patients through a compassionate special permit.
Molnupiravir is an investigational oral antiviral drug developed by Merck & Co. and Ridgeback Therapeutics, which can cut the risk of hospitalization among people with mild to moderate COVID-19 by 50%, according to interim phase III clinical trials.
Merck & Co. is known locally as MSD. Previous media releases indicate that Molnarz will be distributed by Faberco Life Sciences Inc. and RiteMed Philippines Inc., who were selected by Merck & Co. licensed manufacturer Aurobindo Pharma Ltd. to import the drug.
The Philippines has rolled out a series of regulatory approvals amid the worrying threat of the Omicron variant, that appears to be more infectious than the already transmissible Delta variant, which caused a devastating surge in the country from August to September.
Among these are the shortening of the interval for booster doses from six months to three months and the approval of Pfizer-BioNTech’s COVID-19 jab for children aged five to 11.