Gilead (GILD) Drug Gets FDA Nod for Non-Hospitalized COVID Patients

·4 min read

Gilead Sciences, Inc. GILD recently announced that the FDA has approved the label expansion of antiviral treatment Veklury (remdesivir) for COVID-19.

The regulatory body has granted expedited approval to a supplemental new drug application (sNDA) for Veklury (remdesivir) for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death.

It was earlier indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.

The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.

The phase III PINETREE randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. Results showed that treatment with Veklury resulted in a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by day 28 compared with placebo. No deaths were observed in either arm by day 28.

These results were the basis of label expansion of Veklury, pediatric EUA expansion and recently updated National Institutes of Health Treatment Guidelines for COVID-19 that additionally recommend Veklury for treatment in non-hospitalized settings.

The label expansion and EUA extension come amid a surge in COVID-19 cases and the reduced susceptibility to several anti-SARS-CoV-2 monoclonal antibodies (mAbs) due to the Omicron variant.

Per Gilead, Veklury retains activity against the Omicron variant as observed in vitro laboratory testing.

Gilead put up a strong performance in 2021 owing to a solid contribution from Veklury.

Earlier, the European Commission expanded the label for Veklury for use in the early stages of COVID-19 to help prevent disease progression in high-risk patients in the EU amid the rising cases of infection and the emergence of new variants like Omicron.

Sales of Veklury came in at $1.9 billion in the third quarter of 2021 as cases surged mainly amid the Delta variant. In the first nine months of 2021, Veklury sales came in at $4.2 billion.

Shares of this biotech giant have jumped 0.5% in the past year against the industry’s 40.7% decline.

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However, the drug now faces stiff competition from other treatments, especially oral pills, which are much easier than those requiring administration by a healthcare professional.

The FDA granted an EUA to Merck’s MRK and Ridgeback Biotherapeutics’ molnupiravir, an investigational oral antiviral, for the treatment of high-risk adults with mild to moderate COVID-19.

Merck also entered into a procurement agreement with the U.S. Government. It agreed to supply 3.1 million courses of molnupiravir to the U.S. administration upon gaining an EUA from the FDA.

The regulatory body also authorized the emergency use of Pfizer’s PFE oral antiviral treatment Paxlovid for treating mild-to-moderate COVID-19 in adults and pediatric patients. In November 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of Paxlovid, with delivery fulfillment expected to be completed in 2022.

Hence, Veklury sales might be affected next year due to competition from these oral antivirals.

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the sector is Alkermes ALKS, which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Earnings estimates for Alkermes have moved up a cent for 2022 in the past 60 days. ALKS is up 16.4% in the past year.

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