FDA license sought to test Ivermectin in Philippines

MANILA, Philippines — Two pharmaceutical companies intend to apply with the Food and Drug Administration (FDA) to conduct clinical trials in the country using Ivermectin as treatment against COVID-19.

IP Biotech Inc. (IPB), in partnership with Ambica International Inc. (Ambica), recently announced their interest in conducting clinical trials for the anti-parasitic drug here.

“The war against COVID-19 requires a multifaceted approach. While vaccines are the core strategy to resolve this pandemic, we must also supplement this approach with affordable treatments,” said IPB chairman Enrique Gonzalez.

Several clinical trials are underway in other countries to establish the therapeutic effects of Ivermectin on COVID-19 patients, but none in the Philippines. The drug is currently registered in the Philippines as an anti-parasitic drug for animals. However, a number of doctors are recommending its use to combat COVID-19.

Last Thursday, the FDA approved a hospital’s application for a compassionate special permit to be able to use Ivermectin for its patients infected with COVID-19. The permit, however, is not for selling these commercially. It is valid for one year and for one importation by the requesting hospital.

Gonzalez noted that “Ivermectin cannot be used on a mass scale safely unless it is validated through clinical trials and proper FDA registration.”

He underscored that “this is to ensure the safety and efficacy of a product before being made accessible to people.”

“IPB and Ambica seek to work closely with regulators and an independently run clinical trial to validate Ivermectin as a treatment for COVID19,” he added.

According to IPB scientific advisor Noel Miranda, “access to affordable and effective treatments are absolutely necessary,” especially since the end of the COVID-19 pandemic is nowhere in sight.

“The path to herd immunity is not a clear and straight line, partly due to the continued mutation of the virus. While vaccines currently offer a certain level of immunity, the lack of it now means that significant number of Filipinos will still require post-exposure care,” Miranda said.

Ambica vice president Deepu Bhatia has underscored the company’s history of bringing quality pharmaceuticals and affordable medicine to the Philippines.

“Ambica continues to be committed to pioneering affordable, high-quality medicine for Filipinos. We see tremendous potential in the use of Ivermectin in the treatment of COVID-19, subject to clinical trial validation and regulatory approval,” Bhatia maintained. – Janvic Mateo, Louella Desiderio, Emmanuel Tupas