Gilead Falls After Phase 3 Remdesivir 10-Day Trial Failed To Reach Significance

One week after the New England Journal of Medicine found mixed results in its pivotal study of Remdesivir in covid-19 patients which "found no marked benefit from remdesivir for those who were healthier and didn’t need oxygen or those who were sicker, requiring a ventilator or a heart-lung bypass machine" and only "significantly helped those on supplemental oxygen", concluding that  "given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient", moments ago Gilead announced its own results from a Phase 3 trial of Remdesivir in patients with moderate Covid-19 and which, similarly, appeared to disappoint because while the press release was quick to point out that "patients in the 5-day remdesivir treatment group were 65% more likely to have clinical improvement at Day 11 compared with those in the standard of care group," this was not relevant, and what did matter is that "the odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care... failed to reach statistical significance."

The release scrambled to recover the Remdesivir momentum, quoting Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School, who said that "our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve. These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients."

In short, anything to save the drug, even if the drug ultimately does not provide much of a benefit compared to placebo. In the end, it will be up to the FDA to decide whether said lack of significance is enough to grant Gilead drug approval.

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