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www.fdanews.com/articles/200154-who-panel-recommends-against-remdesivir-for-covid-19-patients

WHO Panel Recommends Against Remdesivir for COVID-19 Patients

November 23, 2020

The World Health Organization (WHO) released revised guidance on Gilead Sciences’ antiviral Veklury (remdesivir) after an expert panel review of multiple trials found no evidence for the drug’s effectiveness in treating COVID-19.

In its guidance, the WHO said it offers a “weak or conditional recommendation against the use of remdesivir in hospitalized patients with COVID-19.” More specifically, the panel found “no important effect on mortality, need for mechanical ventilation, time to clinical improvement and other patient-important outcomes.”

The FDA granted full approval to the drug in October for treating hospitalized COVID-19 patients, making it the first approved COVID-19 treatment in the U.S.

And Gilead Sciences is disputing the WHO’s findings. The Foster City, Calif.-drugmaker touted positive data from a multi-part trial directed by the NIH’s National Institute of Allergy and Infectious Diseases, among others, and noted the drug has been approved in more than 50 countries.

“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury,” the company said.

Some experts believe remdesivir can be effective if given to infected patients early in the illness, but WHO said its use should be limited until there is more evidence of efficacy.

Read the WHO’s revised remdesivir guidance here: www.fdanews.com/11-20-20-WHO.pdf. ― Jason Scott