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Application for compassionate use of ivermectin on humans lodged before FDA —Palace

An application for compassionate use of ivermectin on humans has been lodged before the Food and Drug Administration (FDA), presidential spokesperson Harry Roque said Monday. 

Roque made the clarification amid clamor from certain quarters, including lawmakers, for the use of ivermectin on COVID-19 patients and reports that President Rodrigo Duterte agreed on such. 

“Hindi po [ina-approve ito ni Presidente]. Meron na po nag-apply for compassionate use of ivermectin [on humans],” Roque said. 

(The President did not approve of such. What we have is an application for compassionate use of ivermectin on humans.)

“Puwede na po i-process ‘yan ng FDA. Antayin na lang po natin,” he added.

(This application for compassionate use can now be processed by FDA and we will wait for their decision.) 

The FDA has earlier cautioned against using ivermectin on humans.

The existing compassionate use permit issued by the FDA on ivermectin is for animals suffering from parasitic disease.

A compassionate use permit from FDA, however, only allows legal administration of the drug in the country but does not guarantee the drug's safety and efficacy.

The Philippines has recorded 135,526 COVID-19 cases as of Sunday. Of this number, 11,028 new cases were recorded on April 4 alone.

Based on Department of Health records, 58,331 new COVID-19 cases were recorded in Metro Manila in the last two weeks. 

Certificate of product registration

In a DOH briefing earlier on Monday, Health Undersecretary Maria Rosario Vergeire said some local firms have sought a certificate of product registration (CPR) for ivermectin from the FDA.

“Wala pang nag-submit for a clinical trial. Ang mga nakapag-submit ay mga manufacturers, local, ng application for CPR,” she said.

(No one has submitted [an application] for a clinical trial. What was submitted was an application for CPR by local manufacturers.)

FDA chief Eric Domingo said the drug regulator is fast tracking the evaluation of ivermectin.

“Meron din pong naga-apply ng registration dito sa atin. Ang ginagawa naman po namin ay minamadali naman po namin 'yung pag-evaluate ng kanilang mga application,” he said in an interview on Super Radyo dzBB.

(We have received an application for registration. What we are doing is speeding up the evaluation of their application. —KG/KBK, GMA News