/ 9 October 2021

THE FOOD and Drug Administration has issued an emergency use authorization to Ronapreve, a monoclonal antibody, as treatment against Covid19.

FDA Director General Eric Domingo said the agency approved the use of Ronapreve for mild and moderate Covid19 cases for patients 12 years old and above with minimum weight of 40 kg.

“The EUA was only released last week, noong October 1. We also informed the applicant and the Department of Health that this has been issued an EUA,” Domingo said in a media briefing on Friday.

He clarified that medical experts still have to conduct further study before the government could buy the drug and issue guidelines.

“In the countries being used now like in US and UK, the government procures it and then they distribute it to the hospitals. Sa ngayon, since under EUA this is not pre-marketing authorization. It cannot be sold in the market,” Domingo said.

“Only the government and our Covid19 program, ‘yan lang ang makakabili. Kapag nagawa na nila ang guidelines at nakapag-desisyon doon siya magiging applicable to market,” he added.

Domingo explained that Ronapreve is a combination of two virus-neutralizing antibodies that when given in the first few days after the start of Covid19 symptoms, it can reduce risk of hospitalization and death by at least 70 percent.

“Hindi siya (Ronapreve) puwede ibigay sa mga pasyenteng severe Covid19 na nangangailangan ng oxygen o ‘yung mga hirap na hirap na hindi na siya nag-wo-work. At kung late na in the disease, hindi na rin nag-wo-work,” he said.

Ronapreve was developed by foreign biotechnology firms Regeneron and Roche. It was also approved for emergency use in the United States, India, and Canada.