The Food and Drug Administration (FDA) clarifies that Leronlimab is not approved by the FDA for treatment of COVID-19.
Leronlimab is an investigational product which is still undergoing clinical trials for the treatment of Cancer and Human Immunodeficiency Virus (HIV). Now, it is also being investigated for use in the treatment of COVID-19.
Recently, the FDA granted Compassionate Special Permits (CSP) for Leronlimab as requested by medical specialists for the treatment of COVID-19 patients.
It is clarified that a CSP is a special permit granted to physicians or hospitals to use investigational drugs or drugs which are not yet registered or in the process of registration here in the Philippines for the treatment of seriously ill patients. A CSP can only be requested by physicians in charge or by the institution where patients are being treated, who takes full responsibility for the use and dispensing of the requested drug product. 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. 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 1 year.
The public is assured that FDA 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. 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.
The FDA continues to work with the government and private sector to address the effects and impact of this pandemic while adhering to health regulatory standards.