FDA approves emergency use of Ronapreve vs COVID-19

 

MANILA, Philippines — The Food and Drug Administration (FDA) of the Philippines has granted an emergency use authorization (EUA) to the anti-COVID drug  Ronapreve.

“The EUA was only released last week, October 1. We also informed the applicant and DOH (Department of Health) that this has been given an emergency use authorization,” FDA Director-General Eric Domingo said in an online media briefing on Friday.

Domingo clarified that the EUA, just like in vaccines approved for emergency use, is not equivalent to market authorization.

“This is not a marketing authorization. It cannot be sold in the market yet. Only the government and ‘yung ating COVID-19 program, ‘yun lang ang makakabili, at kapag nagawa na nila ang guidelines at nakapagdesisyon, doon siya magiging available,” he said.

(Only the government can purchase it and once guidelines are finalized, then it can be available.)

In August, the United Kingdom’s health regulator approved Ronapreve which it said could help prevent infection, help resolve symptoms of severe COVID-19 infection and reduce the risk of hospitalization.

Japan was the first country to approve the drug to treat mild to moderate COVID-19 infections in July.

Meanwhile, Health Undersecretary Maria Rosario Vergeire said the Philippine COVID-19 Living CPG Reviewers, a group of medical societies, is studying the drug.

“Ngayon, ‘yung mga hospital naman can procure on their own as long as the DOH can provide the recommendation already. We have different processes. Hindi lang EUA ang titingnan. Titingnan din ang rekomendasyon ng DOH dahil ito ay pinag-aaralan din ng ating mga eksperto kung ito ay makakabuti sa panggagamot natin ng COVID-19,” she said.

(Hospitals can procure it on their own as long as the DOH has a recommendation already. We have different processes. We should not just consider the EUA. We will also look at the recommendation of the DOH because our experts are studying whether or not this can be effective in treating COVID-19.)

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