Weaknesses In Gilead's Remdesivir Trial Designs Unlikely to Impact Approval Prospects In US

Gilead Sciences Inc.’s late-stage trial designs for remdesivir, an antiviral being tested in COVID-19, will create challenges to determining the drug’s efficacy and safety in treating the virus. Both of their pivotal trials are open label and only one has a control arm. But experts say those limitations are unlikely to stand in the way of approval of the treatment by the US Food and Drug Administration.

Political pressure, the nature of an urgent pandemic situation, and the FDA’s general willingness over the past few years to approve drugs with less rigorous data, were all cited as factors at play in Gilead’s favor