Anti-viral pill lacks EUA, SRP can’t be issued yet: DOH

By Ma. Teresa Montemayor

October 29, 2021, 1:01 pm

<p>Molnupiravir <em>(Photo courtesy of Merck & Co.)</em></p>

Molnupiravir (Photo courtesy of Merck & Co.)

MANILA – The yet-to-be-approved anti-viral pill molnupiravir still lacks emergency use authorization and no suggested retail price can be issued since it is still under study by regulators, a health official said Friday.

In an online media forum, Department of Health (DOH) Undersecretary Maria Rosario Vergeire noted that some hospitals had been granted compassionate special permit (CSP) to administer the pill that is deemed to cut the risk of hospitalization for adults with mild to moderate symptoms of the coronavirus disease 2019 (Covid-19).

Physicians and hospitals using molnupiravir under CSP are accountable for its outcome on the Covid-19 patients.

“Having said that, hindi pa rin tayo pwede makapag-issue ng SRP (suggested retail price) kasi pinag-aaralan pa ito (we cannot suggest an SRP because it is still under study),” Vergeire said.

“Kelangan lumabas muna ito sa Living CPG Guidelines (Clinical Practice Guidelines) ng DOH para marekomenda at magkaroon ng SRP ang isang gamot (This has to be included in the DOH’s Living CPG Guidelines so it could be recommended and have an SRP).”

READ: Compassionate permit for molnupiravir granted to 4 hospitals: FDA

Since molnupiravir only has a CSP, the government cannot have a tripartite agreement with any entity, she said.

“Hindi pa natin ito pwede ipagbili ng o bumili tayo ng pangmalawakan dahil wala pa po siyang authorization to be used (We cannot sell it yet or purchase it in large amounts because it does not yet have the authorization to be used),” Vergeire said.

Molnupiravir was developed by Merck & Co., which said it is likely to be effective against all known coronavirus variants as it does not target the spike protein of the virus that differentiates the variants.

It comes in a 200 mg. capsule with a recommended regimen of 800 mg. to be taken twice daily for five days or as prescribed by the doctor.

During an online press conference on Wednesday, local importer MedEthix co-founder Monaliza Balnig Salian said the initial delivery of molnupiravir would cover about 300,000 patients.

Salian said it was found out that 81 percent of the 1,200 mild cases taking molnupiravir had negative reverse transcription-polymerase chain reaction (RT-PCR) results on the fifth day of treatment in the clinical trials sponsored by Merck licensee Aurobindo Pharma in India.

Meanwhile, JackPharma, Inc. president Meneleo Hernandez said the market price of molnupiravir “will be established in early November and it will be quite affordable.”

Hernandez estimated the price at PHP100 to PHP130 per pill. (PNA)

Comments