FDA: Ivermectin eligible for special use permit, but no one’s applying  


    THE Food and Drug Administration (FDA) yesterday said those looking to use Ivermectin for coronavirus disease (COVID-19) patients may apply for a compassionate special permit (CSP).

    “Ivermectin is actually eligible for CSP application. But no one is applying,” FDA Director General Eric Domingo said in a televised briefing, referring to drug used to treat parasite infestations in humans and animals.

    The FDA recently advised the public against the use of “Ivermectin veterinary products against COVID-19,” adding Ivermectin products that are registered in the for human use are “for the treatment of external parasites such as head lice and skin conditions.”

    There is a push for Ivermectin’s repurposing as a potential cure for COVID-19 because of its anti-viral properties and immunomodulatory effects.

    Today, the House health committee will hold an online hearing on the Ivermectin issue.

    “We want to know what causes the skyrocketing spike in cases… and we want to know what treatments are available out there so we can save as many patients as possible from this deadly disease,” said panel chair Rep. Angelina “Helen” Tan (Quezon) who is a physician.

    Domingo said nothing is stopping doctors and medical facilities from applying CSP for Ivermectin for use of heir patients.

    “It is eligible since it is also an investigational drug for COVID-19. So, if they want to, they just have to apply with the FDA and complete the requirements,” he added.

    Currently, he said, there is no registered Ivermectin product in the country that can be used for humans, except for those that are for external use.

    “The Ivermectin registered here are for external use, like ointments or lotions for parasites in the skin,” he said.

    “In the Philippines, the only ones registered are those for animals. And it is prohibited to use medicines for animals to humans,” he added.

    Domingo also assured the public that there are enough supplies of remdesivir for COVID-19 patients.

    Remdesivir is an antiviral medication that was developed originally for the treatment of hepatitis C.

    “We called the supplier of the remdesivir with CSP. They said they have available supply and are ready to distribute them,” he noted.

    “Most have stocks on hand and will deliver them this week,” he added.

    Earlier reports said remdesivir stocks in hospitals are running low because of the recent surge in COVID-19 infections.

    At the House, Rep. Enrico Pineda (PL, 1-PACMAN) said there are “actual studies and publications endorsing the effectivity of Ivermectin as treatment for those infected by the COVID-19 virus.”

    Pineda has filed House Resolution No. 1684 seeking an explanation from the FDA regarding its decision on Ivermectin.

    Pineda said he took the drug as prophylactic when he was recovering from COVID-19. He said it is considered cost-effective compared to other repurposed COVID-19 drugs, such as remdesivir which he said costs P28,000 per vial and must be administered twice daily until such time that the patient is discharged.

    “Ivermectin costs only around P35, to be administered once daily for three days, totaling just a little over P100,” Pineda said.

    According to Pineda, Ivermectin has shown so much potential and 22 percent of the world, including India, South Africa and Latin American countries, is using it as COVID-19 treatment and prevention. — With Wendell Vigilia