DOH wants more studies on COVID treatment drug Ronapreve despite FDA EUA

Job Manahan, ABS-CBN News

Posted at Oct 10 2021 01:06 AM

A vial of Regeneron monoclonal antibody via Reuters
A vial of Regeneron monoclonal antibody sits on a medical table as a nurse attempts to find a vein to administer it to a woman vaccinated prior to testing positive for COVID-19, at the Sarasota Memorial Urgent Care Center in Florida, September 23, 2021. Shannon Stapleton, Reuters

MANILA—The health department on Saturday said the country's medical experts need to review the COVID-19 treatment drug Ronapreve before the government buys it for local use. 

The Food and Drug Administration on October 1 granted the emergency use authorization (EUA) of Ronapreve, the first COVID-19 drug to be granted such locally. 

It is also called REGEN-COV in the United States, manufactured by Roche. 

The treatment, a combination of casirivimab and imdevimab, is based on a class of drugs called monoclonal antibodies that mimic natural antibodies produced by the human body to fight off infections.

"The Department of Health said that it has been reviewing the use of Ronapreve together with experts who are continuously updating the Living Clinical Practice Guidelines with regard to its use in the clinical management of COVID-19 patients," the statement read. 

"Moreover, the health technology assessment has to be concluded before hospitals can place an order through the government. Ronapreve cannot be sold in the market since the government is the only one allowed to procure and distribute it."

Health Undersecretary Maria Rosario Vergeire said despite the EUA hospitals could only order it once it is already approved by the DOH and medical experts. 

“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 Health Technology Assessment Council at Living CPG,” said Vergeire.

The HTAC, an independent advisory body under the health department, handles technology appraisals by determining their clinical and economic values in the the country's health-care system. 

Ethical, legal, social and health system implications are also considered in the assessments.

The DOH added that the drug could be used for confirmed COVID-19 patients aged 12 above who are experiencing mild to moderate symptoms. 

It is also recommended to the said patients at least 40 kilograms "who do not need supplemental oxygen and are at high risk of progressing to severe cases." — With reports from Reuters


Watch more on iWantTFC