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Wednesday, October 13, 2021

FDA issues EUA to new Covid drug, but DOH says not so fast!

FOLLOWING THE grant of Emergency Use Authorization (EUA) to Covid-19 treatment drug Ronapreve, the Department of Health (DOH) said it will need a recommendation from the Health Technology Assessment Council (HTAC) and Living CPG (Clinical Practice Guidelines) before the government procures the medicine.

The DOH said that it has been reviewing the use of Ronapreve together with experts who are continuously updating the Living CPG with regard to its use in the clinical management of Covid-19 patients. Moreover, the health technology assessment has to be concluded before hospitals can place an order through the government.

It said Ronapreve cannot be sold in the market since the government is the only one allowed to procure and distribute it.

“Para sa  Ronapreve na may EUA, makaka-order po ang mga ospital kung may approval na ng DOH. Bago po pahintulutan ng gobyerno na mag-place ng order ang mga ospital ng Ronapreve ay dapat may rekomendasyon ito ng ating mga eksperto mula sa HTAC at Living CPG,” said DOH Undersecretary Maria Rosario Vergeire.

Ronapreve is a monoclonal antibody drug to prevent and fight Covid-19. The Food and Drug Administration released the EUA for the drug on October 1 and is authorized for confirmed mild to moderate Covid-19 patients aged 12 and above with a minimum weight of 40 kilos and who do not need supplemental oxygen and are at high risk of progressing to severe cases. (Zamboanga Post)



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