June 4, 2023

The Food and Drug Administration has issued an emergency use authorization (EUA) to Ronapreve, a monoclonal antibody drug to prevent and fight SARS-CoV-2, the virus that cause the Covid-19.

FDA Director-General Eric Domingo said the EUA was released on Oct. 1 and is authorized for patients age 12 and above with a minimum weight of 40 kilograms.

Domingo said the government would conduct a “health technology assessment” first before placing an order.

Ronapreve cannot be sold in the market yet and only the government is allowed to procure and distribute it.

Kapag nagawa na nila ‘yong guidelines at makapag-desisyon doon siya magiging available,” he said.

Ronapreve, a combination of two monoclonal antibodies casirivimab and imbevimab, is being jointly developed by Roche and Regeneron. It is designed to block the infectivity of SARS-CoV-2.

Phase 3 clinical trials show that the drug significantly reduces the viral load within seven days of treatment in patients hospitalized with mild to moderate Covid-19.

Domingo said it cannot be given to severe cases or those who already require oxygen because it would no longer work if they are already late into the disease.

As of Sept. 30, Ronapreve has been approved for use in different patient populations in Japan and conditionally in the United Kingdom, and is authorized for emergency use in the United States, India, and Canada. – PNA