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MANILA - The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Ronapreve, a monoclonal antibody drug to prevent and fight SARS-CoV-2. FDA Director General Eric Domingo on Friday said the EUA was released on October 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 (Once they've crafted the guidelines and have made a decision, that's that time it will be made 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 tria

United statesUnited kingdomDrug administrationGeneral eric domingoManila the food and drug administration fda has issued an emergency use authorization eua to ronapreveA monoclonal antibody drug to prevent and fight sars cov 2 fda director general eric domingo on friday said the eua was released october 1 is authorized for patients age 12 above witha minimum weight of 40 kilograms government would conducta quot health technology assessment first before placing an order ronapreve cannot be sold in market yet only allowed procure distribute it kapag nagawa na nila 39 yong guidelines at makapag desisyon doon siya magiging available once they ve crafted have madea decisionHat 39s that time it will be made availableUot he said ronapreveA combination of two monoclonal antibodies casirivimab and imbevimabS being jointly developed by roche and regeneron it is designed to block the infectivity of sars cov 2 phase 3 clinical trials show that drug significantly reduces viral load within seven days treatment in patients hospitalized with mild moderate coronavirus disease 2019 covid 19 domingo said cannot be given severe cases or those who already require oxygen because would no longer work if they are late into as september 30Onapreve has been approved for use in different patient populations japan and conditionally the united kingdomNd is authorized for emergency use in the united statesNd canada pna