WHO Advises Against Gilead's Remdesivir For COVID-19 Despite FDA Approval

The United Nations World Health Organization said Thursday that Gilead Sciences Inc’s  GILD remdesivir is not recommended for the treatment of COVID-19, the Wall Street Journal reports. 

What Happened: The international agency’s panel, which advises it on treatments, made the recommendation against the drug based on data from four global trials that compared the effects of several drugs, according to the Journal.

The WHO said that remdesivir “has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement.”

Remdesivir — sold under the brand name Veklury — is recognized as the standard of care for hospitalized patients in the United States, Japan, the United Kingdom, and Germany, Gilead said.

The drugmaker pointed out that the treatment is based on multiple studies published in peer-reviewed journals.

Gilead expressed disappointment with WHO guidelines, claiming that they “appear to ignore this evidence” at a time when doctors and the world rely on its drug as the “only approved antiviral treatment for patients with COVID-19 in approximately 50 countries.”

Why It Matters: The U.S. Food and Drug Administration fully-approved remdesivir for use in COVID-19 patients, aged 12 and above, in October. The Gilead drug had received emergency use authorization from the FDA in May. 

A global WHO study earlier found that remdesivir had “little or no effect on mortality on hospitalized COVID-19” patients. 

In October, WHO said it would also evaluate other treatments such as Regeneron Pharmaceuticals Inc REGN and Eli Lilly And Co's LLY  antibody cocktail therapies.

Last month, Gilead slashed its earnings guidance for 2020 on underwhelming demand for remdesivir.

Price Action: Gilead shares closed almost 0.4% lower at $60.63 on Thursday and fell 1.62% in the after-hours session.

Photo courtesy: Yann Forget via Wikimedia