Pharmaceutical company applies for registration of ivermectin for COVID-19 patients, say officials
A local pharmaceutical company, along with doctors of individual patients, has applied for the compassionate use of ivermectine for patients infected with coronavirus disease, officials said on Monday.
Presidential Spokesperson Harry Roque, in a televised press briefing, said that during the almost 10-hour meeting of the Inter-Agency Task Force for the Management of Emerging Infectious Diseases last Saturday, one of the agenda was the use of ivermectin.
He said Food and Drug Administration Director General Rolando Enrique Domingo reported that there was an application for compassionate use of ivermectin.
"So that can be processed already by the FDA, unlike before, no one applied. So, let's wait for the FDA action on the filed application for ivermectin," he said.
In a text message, Domingo said Lloyd Laboratories, Inc., a local pharmaceutical company, applied last Wednesday for the certificate product registration for ivermectin.
This is on top of the applications by doctors for their individual patients, he said.
Asked of the likelihood that Lloyd Laboratories's application will be approved, Domingo told the Manila Shimbun, "It is being evaluated. I cannot say the likelihood."
Some quarters, including local politicians, have been asking President Rodrigo Duterte to order the FDA to allow the use of ivermectin to treat COVID-19 patients.
Due to previous non-action of the FDA, critics were even calling for Domingo's removal.
World Health Organization Reprensentative in the Philippines Rabindra Abeyasinghe, in the same press briefing, urged the public to refrain making any conclusion regarding ivermectin and allow the scientists to do what they have to do.
"I will start by saying that probably, the fight against the infodemic has been even more difficult than to fight against the pandemic. There have been situations where this kind of misinformation has been driving and infecting on the capacity of national government to respond to the pandemic because they are seriously distracting technical people form doing what they need to do," he said.
He noted that even the largest manufacturer of ivermectin claimed that its product has not proven efficacy to treat COVID-19.
"Even if we look at it from preventive prospective there is no evidence that the supports it," he said.
Abeyasinghe said this was why WHO came out with a "very clear position" that the potential use of ivermectin as prophylactic or therapeutic agent needs to be evaluated through an equally strong clinical trials and not just the solidarity trials.
"Let us remember, COVID-19 many patients recovered because it’s a viral disease without any specific treatment provided they have good immune systems. More than 95 percent of them recovered without specific treatments. So if you give those patients a particular drug and see that that drug cure them. That is not science; that is not evidence. And this is what happening again with possibly, ivermectin," he explained.
"That is why WHO says, let’s do clinical trial that has the power to differentiate whether what we have seen is because of chance, or there is the actual efficacy of the drug. When we have that evidence, we will be ready to share," the WHO official added. Celerina Monte/DMS