Leronlimab is not approved for the treatment of the coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said over the weekend.
In an advisory issued April 17, the FDA said that Leronlimab is an investigational product which remains under clinical trials for the treatment of cancer and human immunodeficiency virus (HIV).
But, the agency noted that the drug is now also being investigated for use in the treatment of COVID-19.
Despite this, the FDA revealed that it granted Compassionate Special Permits (CSP) for Leronlimab to undisclosed medical specialists for the treatment of COVID-19 patients.
The agency explained that a CSP may be granted to doctors or hospitals to use investigational drugs, unregistered drugs, or drugs in the process of registration in the country for the treatment of seriously ill patients.
A CSP holder also takes full responsibility for the use and dispensing of the drug.
“The CSP holder must fully inform the patient of the investigational status of the product, and provide a report to the FDA of the outcomes for every patient given the product,” the FDA said.
“This permit is given only to qualified medical specialists/institutions who are authorized to use the product to a specific number of patients with an estimated small volume, and is valid for one year,” it added.
The regulatory agency assured the public that it recognizes the potential help of investigational products to manage COVID-19.
“FDA ensures that access to these types of drugs is in place in the Philippines. However, while a CSP grants access to investigational drugs, such as Leronlimab, the permit is not intended to replace the prescribed drug registration process which involves a systematic evaluation of evidence-based data,” the advisory read.
“It must be stressed that an approved CSP is not a Certificate of Product Registration (CPR) or an Emergency Use Authorization (EUA), hence it is not an assurance of the product quality, safety, and efficacy. No product granted with CSP can be marketed commercially,” it added.