FDA Commissioner Stephen Hahn speaking at the March 19 Coronavirus Task Force press briefing
A drug that Gilead Sciences originally developed to treat the Ebola virus and is now in clinical trials for the Covid-19 virus is available on a compassionate use basis for the pandemic coronavirus as well, a top official from the Trump administration’s Coronavirus Task Force said Thursday.
Speaking at the task force’s daily press briefing, Food and Drug Administration Commissioner Stephen Hahn highlighted the availability of the Gilead drug, GS-5734 (remdesivir), under compassionate use in addition to its testing in ongoing clinical trials as a treatment for SARS-CoV-2.
Compassionate use is a longstanding FDA program that allows for a physician to use an investigational drug in a patient under a protocol that undergoes review by an institutional review board and the FDA itself, while in addition enabling the agency to collect data. Although President Trump had referred to the program as “beyond Right To Try,” it differs markedly from that program, which also allows patients to obtain investigational drugs, but without FDA oversight or the ability to collect regulatory-grade clinical data.
Still, when it comes to giving patients investigational drugs to treat Covid-19, “We want to do that in the setting of a clinical trial – a large, pragmatic clinical trial,” Hahn said.
Other investigational drugs that came up included hydroxychloroquine, a 65-year-old generic drug approved to treat malaria and certain autoimmune disorders.
Remdesivir drew interest as a potential treatment for coronavirus due to the previous publication of preclinical data indicating that it had activity against other coronaviruses, including the SARS coronavirus of 2002-2003 and the Middle East respiratory syndrome (MERS) coronavirus. Early in the outbreak, the New England Journal of Medicine published an anecdotal account of a coronavirus patient in Washington state who took the drug and saw his symptoms clear up within days. A clinical trial was soon after launched in China.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The ClinicalTrials.gov database currently lists four active studies of the drug in the U.S. and elsewhere, including an expanded access protocol. The larger clinical trials include two Phase III trials of 400 and 600 patients sponsored by Foster City, California-based Gilead itself. Those trials have sites in the U.S., Hong Kong, South Korea and Singapore. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is running a randomized Phase II trial of 394 patients as well that also includes sites in Korea and Singapore.
Data for remdesivir are anticipated to become available as early as next month.
The University of Minnesota is running a randomized 1,500-patient Phase II/III trial testing hydroxychloroquine as a post-exposure prophylaxis against SARS-CoV-2. A 30-patient Phase III trial in Shanghai is investigating it for treatment of Covid-19-related pneumonia, and a 150-patient Phase II study in Korea is comparing it with AbbVie’s HIV drug Kaletra (lopinavir, ritonavir). However, in a NEJM paper Wednesday, Chinese researchers wrote that Kaletra as a single agent had failed to show benefit.
Photo: Brendan Smialowski, AFP, via Getty Images
