Real-world repurposing of off-patent drugs for off-label use can provide immediate treatment options for COVID-19 patients who have no time to wait.

Key Messages

During global or individual health emergencies where no approved treatments are available, off-label drug use (also called “real-word drug repurposing”) may offer the only hope for a treatment or cure.

COVID-19 disrupts a wide range of physiological functions and affects multiple organs in the body. Therefore, drugs that target multiple physiological processes are essential for treating the disease.

This article reviews the evidence for six generic drugs, including fenofibrate, which target the physiological processes disrupted by COVID-19 to help reverse the disruption.

Previous studies have revealed that fenofibrate reduces hardening of the arteries to protect against death or disability caused by cardiovascular disease and stroke. Furthermore, it can protect against kidney deterioration and has an effective antiviral activity in patients infected with the hepatitis C virus.

Fenofibrate also has the potential to treat the serious hyper blood clotting activity seen in many severe COVID-19 patients. It drastically reduces blood plasma levels of fibrinogen and d-Dimer, which are proteins involved in blood clotting.

The multi-target activities of fenofibrate, in addition to its three-decade history of safe use make this drug an excellent candidate for an off-label drug to treat COVID-19.

JMIR Public Health and Surveillance

Publication Date: May 13, 2020
Peer Reviewed: Yes
Publication Type: Original | Theoretical
DOI: https://www.doi.org/10.2196/19199

Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point

Moshe Rogosnitzky, Esther Berkowitz, Alejandro R Jadad

Abstract

Real-world drug repurposing—the immediate “off-label” prescribing of drugs to address urgent clinical needs—is a widely overlooked opportunity. Off-label prescribing (ie, for a nonapproved indication) is legal in most countries and tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, health crises may mean that real-world repurposing is the only realistic source for solutions. Optimal real-world repurposing requires a track record of safety, affordability, and access for drug candidates. Although thousands of such drugs are already available, there is no central repository of off-label uses to facilitate immediate identification and selection of potentially useful interventions during public health crises. Using the current coronavirus disease (COVID-19) pandemic as an example, we provide a glimpse of the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and targeted toward the underlying pathophysiology that makes COVID-19 so deadly. This paper briefly summarizes why cimetidine or famotidine, dipyridamole, fenofibrate or bezafibrate, and sildenafil citrate are worth considering for patients with COVID-19. Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our health care systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.