2 local pharmaceutical firms eye production of Ivermectin

MANILA, Philippines — Two local pharmaceutical firms have expressed interest to apply for registration with the Food and Drug Administration (FDA) for the production of Ivermectin for human use for treatment of COVID-19, the Anti-Red Tape Authority (ARTA) said.

Lloyd Laboratories and Pascual Laboratories expressed willingness to apply for registration for the production of Ivermectin for human use during a meeting with the FDA yesterday, ARTA director general Jeremiah Belgica said at a press briefing.

According to FDA director general Eric Domingo, the application for emergency use is the most convenient option for firms that want to manufacture Ivermectin, provided it is included in the COVID-19 treatment protocol.

Belgica said the agency would meet with officials of the FDA and Department of Health today to discuss the possible inclusion of the drug in the treatment plan.

In response to the pharmaceutical groups and associations’ clamor to have Ivermectin made available for COVID-19 patients’ use, Domingo said hospitals and doctors may use the drug under a Compassionate Special Permit (CSP) in the meantime.

The application process for CSP would take 24 to 48 hours if all requirements have been complied with.

Earlier, Domingo said there is currently no registered Ivermectin oral formulation for human consumption.

For human use, Ivermectin is currently registered with the FDA as a prescription drug in topical form for the treatment of external parasites such as head lice and skin conditions such as rosacea.

The FDA said Ivermectin is also approved for animal use as an oral and intravenous preparation for the prevention of heartworm disease and treatment of internal and external parasites and should be administered according to its approved indication, or as prescribed by a veterinarian.

Belgica encouraged firms to comply with the applications necessary to be able to use Ivermectin.

He said the ARTA would ensure the applications are acted upon within the required processing time.

He also called on the FDA to take appropriate action against the pharmaceutical company that was asked to discontinue the compounding of Ivermectin after being mistaken as a manufacturing company.

An infectious disease expert from the University of the Philippines-National Institute of Health (UP-NIH) has cautioned the public that there is no clinical evidence that Ivermectin could be used to prevent and treat COVID-19.

Edsel Salvana, director of the UP-NIH Molecular Biology and Biotechnology, said he is not totally against Ivermectin but ongoing clinical trials do not show “clear benefits at this time.”

“I am a trained parasitologist so I’m very familiar with the drug. I am not dismissing that it might work (against COVID) but we need to wait for the clinical data,” he posted on his Facebook account.

Salvana said Ivermectin can be used against COVID-19 if there is “good clinical data.”

He noted that Ivermectin manufacturer Merck had earlier cautioned against its use. The drug company has not applied with the FDA for compassionate use or registration of the drug for COVID-19.

“Be careful if somebody sells you Ivermectin. It could be fake,” he said. “They use this for worms in animals, but the dosing is different and the additives may be harmful to humans or it might contain the wrong dose.” – Sheila Crisostomo