The Food and Drug Administration’s decision to grant a full approval to Gilead Sciences Inc.’s Veklury (remdesivir) is raising questions about the broader value of a drug that has been praised for being “first” but may only provide limited clinical benefits. The basis of the Veklury authorization was the antiviral drug’s ability to help hospitalized patients recover faster in NIH-sponsored research. However, the NIH studies didn’t definitively prove Veklury prevented COVID-19 deaths, but suggested a possible benefit among certain, less-sick patients.
Other studies, including two trials in China and one conducted by the World Health Organization, have found little benefit in Veklury. The WHO’s Solidarity trial is a randomized, open-label study evaluating four antiviral drugs, including Veklury, in 11,330 hospitalized patients around the world; it found that the drugs had “little or no effect” on mortality, the need for ventilation or duration of hospital stay, according to interim findings published Oct. 15 in preprint form, meaning they haven’t been peer-reviewed. Gilead contests these findings.
“While the Solidarity trial provided information about Veklury in real-world settings in the early days of the pandemic, it does not negate other study results,” Dr. Merdad Parsey, Gilead’s chief medical officer, said in a statement announcing the FDA approval.
Dr. Peter Bach, an epidemiologist and director of Memorial Sloan Kettering Cancer Center’s Center for Health Policy and Outcomes, called the approval “astonishing” in a tweet, before criticizing the use of clinical trials that either lacked a control arm or blinding in the approval. “An entirely negative real-world [randomized controlled trial] was larger than these put together,” Bach tweeted. “‘Effective’? What?”
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(Source: Jaymie Lee; MarketWatch; 11/5/20)