Antiviral Remdesivir Reportedly Shows More Promise in Clinical Trial

April 17, 2020 (EIRNS)—STAT reported yesterday that “a peek” at the results of an ongoing trial in Chicago hospitals of the antiviral drug remdesivir shows evidence of promising results in treating COVID-19 patients. University of Chicago Medical Center recruited 125 patients into a larger Phase 3 trial sponsored by Gilead Sciences, wherein all patients receive the investigational drug daily; 113 of those patients are described by STAT as “severely” ill, but none were on respirators. “ ‘The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,’ said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.” Mullane reported on a video to University of Chicago faculty of which STAT obtained a copy—from whom, is not known.

Gilead Sciences said: “We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir. The totality of the data need to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19. We expect the data from our Phase 3 study in patients with severe COVID-19 infection to be available at the end of this month, and additional data from other studies to become available in May.”

A Phase 3 trial compares the efficacy of the drug to the “standard of care” without it. “Positive results would likely lead to fast approvals by the Food and Drug Administration [FDA] and other regulatory agencies,” reports STAT.

In that fortunate event, cost and availability of the drug would become the major issue. The Intercept, and then other publications, reported on March 23 that the FDA had given Gilead “orphan drug” status for remdesivir, which was used to treat Marburg virus. Pharma companies can charge very high prices for “orphan” drugs which treat only rare conditions. The publicity made Gilead abandon the claim. This may allow FDA approval of generic versions. But Gilead Sciences, a California-based pharma company which has annual revenues near $30 billion, has been challenged for charging excessive prices for its antiviral drugs. https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/