Friday, April 29, 2022

After WHO trial failure, influential medical group advises against Gilead’s remdesivir in COVID critical care: Reuters

Gilead’s remdesivir, now known as Veklury, is perhaps the most successful COVID-19 drug so far. It scored a full FDA nod in October after months of emergency use and brought in $873 million last quarter as the standard of care in hospitalized patients.

But there are questions about how well Veklury works—and now, an influential European medical association says it shouldn’t be used in intensive care units.

In the wake of a large World Health Organization study showing no benefit for the medicine in hospitalized patients, remdesivir is “now classified as a drug you should not use routinely in COVID-19 patients” requiring critical care, Jozef Kesecioglu, president of the European Society of Intensive Care Medicine, told Reuters. 

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The group, along with the U.S. Society of Critical Care Medicine, plans to present the recommendations in an upcoming paper about COVID-19 medicines, Kesecioglu told the news service. In the first version of the paper, back in March, the experts said there wasn’t enough data to recommend the med yet. 

Gilead told Reuters in a statement it’s “confident that doctors on the front lines recognize the clinical benefit of Veklury based on robust evidence from multiple randomized, controlled studies.” 

RELATED: Gilead scored a full FDA approval for COVID-19 drug Veklury, but experts aren’t convinced

ESICM represents thousands of intensive care doctors in more than 100 countries. While its doctors aren’t required to follow recommendations, the group’s stance could reduce overall remdesivir use, Reuters reports. 

The episode is the latest dramatic turn in a months-long debate over evolving data on Veklury.

Controlled trials have shown Veklury is associated with “clinically meaningful improvements across multiple outcome assessments” in hospitalized patients, Gilead said at the time of its FDA approval last month. Those data have led doctors to turn to the medicine as the standard of care for hospitalized patients, the company added.

But a week before the FDA approval, a large World Health Organization study found the medicine “appeared to have little or no effect” in patients hospitalized with COVID-19. Gilead hit back at the results, saying the data hadn’t “undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”

RELATED: Gilead Sciences takes back remdesivir distribution as demand drops

Plus, because the trial prioritized broad access, there were so many variables in the patient population that it’s “unclear if any conclusive findings can be drawn from the study results,” the company said. 

Despite the debate, the medicine has been in high demand throughout the pandemic, causing supplies to run low at times. Doctors used the Gilead drug and other medicines in treating President Donald Trump, and in the third quarter, Gilead reported $873 million in sales from the medicine. 

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