Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defense

Gilead Sciences’ Veklury, better known as remdesivir, is so far the only COVID-19 therapy officially approved by the FDA, but the World Health Organization has some other ideas about the drug’s worth.

At clear odds with the FDA’s approval, the WHO has for now recommended against the use of remdesivir in any hospitalized patients—regardless of disease severity—after an expert panel said it had found no evidence that remdesivir has any meaningful effect on saving lives and other important outcomes for patients, the international body said Thursday.

A “disappointed” Gilead immediately fought back. It pointed to remdesivir’s inclusion in several other organizations’ guidelines based on data from a phase 3 trial by the National Institute of Allergy and Infectious Diseases (NIAID), which showed the drug’s use could lead to faster recovery.

Debate over remdesivir’s utility in COVID-19 has been ongoing for a while, especially when the FDA turned a previous emergency use authorization into a full approval in October.

In reaching their current recommendation, the WHO guidance development experts went through data from four clinical trials involving more than 7,000 participants but found “a lack of evidence that remdesivir improved outcomes that matter to patients, such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and others,” they said in The BMJ.

That’s the part Gilead took issue with. In the NIAID-run ACTT-1 trial, remdesivir use helped hospitalized patients recover five days faster than the placebo group did, although the benefit was largely driven by patients who required some oxygen support but not mechanical ventilation.

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The WHO, through its meta-analysis, also found those with noncritical disease might benefit from remdesivir. “However, the panel judged the credibility in this subgroup analysis to be insufficient to make subgroup recommendations,” it said.

The WHO’s skepticism mainly came from its own large-scale Solidarity trial, which found the drug offered no benefit, including where patients' death rate, length of hospital stay or need for ventilation was concerned. Gilead has been labeling the Solidarity study’s findings as less robust because of shortfalls in trial design.

The trial was carried out in different parts of the world, with discrepancies in trial implementation and control choice, Gilead has said. But the Solidarity team has painted this geographic diversity as a main advantage of the study, arguing it offers a global look at remdesivir’s potential in complex real-world settings.

RELATED: COVID-19 fighter remdesivir racks up $873M as Gilead plays defense on unflattering WHO data

In addition to the data, the WHO panel also considered the “costs and resource implications” associated with remdesivir. It raised concerns about the opportunity costs of drawing resources away from other best supportive care to remdesivir, and about the drug’s intravenous route, which could cause access problem in some parts of the world.

Despite the current “no” ruling, the WHO experts still support further enrollment into clinical studies “to provide higher certainty of evidence for specific subgroups of patients.” The recommendation, as part of a so-called “living guideline” on COVID-19, is up for updates as new evidence rolls in.  

Gilead has set remdesivir’s list price at $3,120 for a standard five-day treatment course for private insurance plans in the U.S. In the third quarter, the drug hauled in $873 million for Gilead. But the company—as well as industry watchers—has lowered its sales expectations for the drug. As COVID vaccines draw near, questions have also targeted all treatments’ mid-to-long-term value for their developers.