Gilead Sciences, Inc. GILD announced that the FDA has expanded the Emergency Use Authorization (EUA) for its investigational antiviral, Veklury, for COVID-19 infection.
Veklury can now be used to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
The approval for expanded use was based on results from the phase III SIMPLE trial, evaluating Veklury in hospitalized patients with moderate COVID-19 pneumonia, and results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.
We note that Gilead initiated two randomized, open-label, multi-center international phase III studies on Veklury, the SIMPLE studies, in countries with a high prevalence of COVID-19 infections.
Results from the phase III SIMPLE study were recently published in the Journal of the American Medical Association (JAMA) and confirm the top-line results previously announced. The primary endpoint evaluated patients at day 11 on a 7-point ordinal scale and found patients randomized to a 5-day course of Veklury plus standard of care were 65% more likely to see an improvement in clinical status compared with those randomized to standard of care alone. However, for patients in the 10-day Veklury group, the improvement in clinical status at day 11 was not statistically different compared with the standard of care group.
Meanwhile, multiple ongoing international phase III studies are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2 infection.
Gilead’s stock has gained 0.7% in the year so far compared with the industry‘s growth of 1.2%.
In fact, remdesivir is pioneering the race for a possible treatment of this deadly virus.
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is running a race against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.
Roche RHHBY initiated a late-stage study on its arthritis drug, Actemra/RoActemra, in combination with remdesivir in hospitalized patients with severe COVID-19 pneumonia.
We note that Regeneron REGN initiated studies on REGN-COV2, a novel investigational antibody cocktail treatment designed to prevent and treat the SARS-CoV-2 virus.
Amgen’s AMGN Otezla is being investigated as a potential immunomodulatory treatment in patients hospitalized with SARS-CoV-2 infection in multiple COVID-19 platform trials.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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