Gilead’s remdesivir gets FDA emergency authorization for Covid-19

While not necessarily seen as a game changer, the drug is seen as likely to become a first-line standard of care for Covid-19 given the lack of approved treatments. The EUA follows positive data from an NIH-sponsored trial that were announced earlier this week.

The Food and Drug Administration has granted an anticipated emergency use authorization to a drug that may be able to treat patients with Covid-19.

The agency said Friday that it had given the EUA to Gilead Sciences’ remdesivir for adult and pediatric patients hospitalized with suspected or laboratory-confirmed severe Covid-19.

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Although shares of the Foster City, California-based biotech company were down 4.8% on the Nasdaq when markets closed Friday following the announcement of its first-quarter financial results, they were up 1.7% in after-hours trading following news of the EUA.

The EUA – which is not a full approval but allows for the drug’s use for the pandemic disease – follows the announcement earlier this week of early data from a randomized, placebo-controlled Phase III study in 1,063 patients sponsored by the National Institute of Allergy and Infectious Diseases. The same day the results from the NIAID trial were released, the company also announced data on a 397-patient sample from SIMPLE, its Phase III study in patients with severe disease, which was considered less definitive because it lacks a control arm. The New York Times had reported that an EUA was expected.

The NIAID study showed that patients who received remdesivir recovered four days faster than those who received placebo, in a median of 11 days, compared with 15 days for the control arm, translating into a 31% faster recovery. There was also a trend in survival that favored patients in the remdesivir arm – with an 8% mortality rate, compared with 11.6% among patients on placebo – but that did not reach statistical significance.

“The EUA system was designed by Congress to be used in situations like this in order to provide therapies to patients as soon as possible,” wrote Chad Landmon, an attorney at the law firm Axinn and chair of its FDA practice group, in an email. “Although the study results that we have on remdesivir are still preliminary, and although remdesivir is continuing to undergo additional evaluation and study, doctors will now have an additional tool to use that has shown some promise in treating patients.”

In a note to investors Wednesday, RBC Capital Markets analyst Brian Abrahams called the NIAID study data impressive, while Baird analyst Brian Skorney wrote that the results on time to recovery were “clearly positive,” notwithstanding the lack of statistical significance in mortality rate. On the other hand, Skorney and others have pointed to a randomized study in China that was stopped before being fully enrolled, but that produced a negative outcome, with results published in The Lancet. Given that in that study, remdesivir was not shown to have an antiviral effect, “we continue to be skeptical that Gilead’s antiviral will have a game changing effect in COVID-19,” Skorney wrote.

Photo: Ulrich Perrey, Pool/AFP, Getty Images