(FILE) Food and Drug Administration Director General Eric Domingo. Consuelo Marquez, INQUIRER.net FILE
MANILA, Philippines — The Food and Drug Administration (FDA) has granted a compassionate special permit (CSP) to two physicians for the use of Leronlimab to treat COVID-19 patients.
“Recently, the FDA granted Compassionate Special Permits for Leronlimab as requested by medical specialists for the treatment of COVID-19 patients,” the FDA said in a statement over the weekend.
Leronlimab is an investigational product still undergoing clinical trials for the treatment of cancer and human immunodeficiency virus.
It is also being investigated for use in COVID-19 treatment.
In a text message to INQUIRER.net on Monday, FDA Director General Eric Domingo said the CSP was given to “two physicians for two patients” but refused to divulge more information, citing patient privacy.
However, the FDA clarified that the product is not yet generally approved for COVID-19 treatment.
“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,” the FDA said in its statement.
The drug regulator noted that a CSP can only be requested by doctors in charge or by the institution where patients are being treated, who takes full responsibility for the use of the requested drug product.
The FDA also said that the CSP holder must fully inform the patient of the investigational status of the product, and provide a report of the outcomes for every patient given the product.
The permit, said the FDA, is granted only to qualified medical specialists or institutions authorized to use the product to a specific number of patients with an estimated small volume. It added that the CSP is valid for one 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,” the FDA said.
“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 agency noted.
The FDA further stressed that a CSP does not equate with a Certificate of Product Registration or an Emergency Use Authorization, thus it is not an assurance of the product’s quality, safety, and efficacy.
It added that no product granted a CSP can be marketed commercially.
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