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www.fdanews.com/articles/203282-gilead-sciences-claims-remdesivir-reduces-covid-19-mortality-risk

Gilead Sciences Claims Remdesivir Reduces COVID-19 Mortality Risk

June 22, 2021

Gilead Sciences has said its antiviral Veklury (remdesivir) reduced hospitalization and death rates for COVID-19 patients, based on new results from three real-world studies.

The company, which evaluated data from 98,654 people, claimed all three studies showed that patients treated with remdesivir had significantly lower risk of mortality compared with placebos, while two studies showed patients receiving the drug had significantly better odds of hospital discharge by day 28 following a five-day treatment course.

The Foster City, Calif., drugmaker said the findings were consistent throughout different pandemic timeframes and territories.

But it remains unclear whether the new analysis will assuage remdesivir’s critics. The antiviral, which received an Emergency Use Authorization in May 2020, drew pushback when it gained full FDA approval in October because it was done without input from an independent advisory committee and critics argued there was no compelling reason for the agency to change its status (DID, April 22).

A World Health Organization review of multiple trials late last year found remdesivir offered no meaningful clinical benefit for treating COVID-19 patients (DID, Nov. 23, 2020), prompting regulators like the FDA to downplay recommending its use.

Still, remdesivir has proved to be a blockbuster for Gilead during the pandemic. The treatment generated global sales of $2.8 billion in 2020. — Jason Scott