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Gilead's Veklury Study Shows Faster COVID-19 Recovery, Reduced Disease Progression, Mortality

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Gilead's Veklury Study Shows Faster COVID-19 Recovery, Reduced Disease Progression, Mortality

Gilead Sciences, Inc. (NASDAQ: GILD) shares were trading higher Friday after the company announced the publication of final results from the Phase 3, NIAID-sponsored trial of Veklury in adults hospitalized with mild-to-moderate COVID-19.

What Happened: The final results of the ACTT-1 study published in the New England Journal of Medicine showed that treatment with Veklury — generic name remdesivir — resulted in "consistent, clinically meaningful improvements" across multiple outcome assessments compared with a placebo in COVID-19 patients, Gilead said in a release.

Treatment with Veklury resulted in a faster time to recovery than previously reported, the company said. 

Preliminary day 15 results showed that Veklury plus the standard of care shortened the time to recovery by four days compared with a placebo plus standard of care. 

The primary endpoint of showing superiority in shortening the time to recovery through day 29 relative to a placebo plus standard of care was met, Gilead said.

The median time to recovery with Veklury was 10 days compared to 15 days for the control arm. The recovery rate was higher with Veklury, the company said.

The key secondary endpoint of clinical status at day 15 was also met, with patients who were receiving Veklury being 50% more likely to have improved by day 15 compared to the control arm. The effect was maintained through day 29. 

Veklury was also associated with a reduced mortality rate relative to placebo at days 15 and 29. 

"Overall, the incidence of adverse events associated with Veklury was similar to placebo, with no new safety signals identified as compared to the interim analysis," Gilead said.

Related Link: The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO

Why It's Important: With the data demonstrating that Veklury reduces disease progression, the investigational treatment is likely to keep patients from progressing to the need for supplementary oxygen or higher levels of respiratory support.

"In addition to the direct impact on patients, these outcomes represent clear benefit and value to healthcare systems. Remdesivir could help to lower the use of health care resources and reduce the number of days that patients are in the hospital," Gilead CEO Daniel O'Day said in an open letter.

The company has sought for full approval for Veklury, and this data should only serve to strengthen the case.

Veklury Supply Arrangements: Gilead is in possession of enough Veklury to treat all hospitalized patients in the U.S., even in the event of a future spike, O'Day said.

"Globally, we expect to meet demand this month, enabling the purchase of Veklury both to treat current hospitalized patients and to support national stockpiling," the CEO said. 

The company has an agreement with the European Commission to help 37 participating countries in the EU and the European Economic Area as well as the U.S. provide remdesivir to meet real-time demand and stockpiling.

The company also said its voluntary licensing partners are supplying generic remdesivir in more than 40 countries.

GILD Price Action: Gilead shares were up 1.2% at $64.08 at last check Friday. 

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

Photo courtesy of Gilead. 

 

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Posted-In: Coronavirus Covid-19 remdesivir VekluryBiotech News Health Care General Best of Benzinga

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