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Regeneron's (REGN) Cocktail Gets EUA for COVID-19 by FDA

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has given Emergency Use Authorization (EUA) to its antibody cocktail, casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19.

The FDA grants EUA to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available.

The antibody cocktail is authorized for the treatment of mild to moderate COVID-19 in adults, as well as pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

However, the cocktail is not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

The authorization is based on positive phase II data from the first 799 adults in an ongoing randomized, double-blind, placebo-controlled trial of non-hospitalized patients (“outpatients”) with COVID-19. Data showed that non-hospitalized patients showed significant reductions in virus levels within days of receiving the combination, along with significantly fewer medical visits. The benefit experienced was highest in patients most at risk for poor outcomes due to high viral load, an ineffective immune response at baseline or pre-existing risk factors.

Evaluation of the cocktail combination’s safety and efficacy is ongoing in multiple clinical studies and data from these studies will be used to support a future biologics license application (BLA) submission. The casirivimab and imdevimab combination therapy continues to be evaluated in phase II/III studies for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, the phase III open-label RECOVERY study in hospitalized patients in the U.K., and a phase III study for the prevention of COVID-19 in household contacts of infected individuals.

We remind investors that as part of Operation Warp Speed, the U.S. government and Regeneron signed an agreement for this initial supply of the casirivimab and imdevimab antibody cocktail. The U.S. government will coordinate with state authorities to allocate the antibody cocktail on a weekly basis, based on the number of COVID-19 cases in each state. Regeneron expects to have treatment doses ready for approximately 80,000 patients by the end of November, 200,000 by the first week of January, and roughly 300,000 in total by the end of January 2021.

Regeneron’s shares have surged 38.1% in the year so far against the industry’s decline of 0.9%.

Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing 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 pharma/biotechs are developing antibodies or evaluating their approved drugs or pipeline candidates to determine if they are effective enough to treat the infected patients.

Eli Lilly and Company (LLY - Free Report) and partner Incyte (INCY - Free Report) too recently announced that the FDA has issued an EUA for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory-confirmed COVID-19, who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

However, the World Health Organization (WHO) recently issued a conditional recommendation against the use of Gilead Sciences’ (GILD - Free Report) remdesivir in hospitalized COVID-19 patients, regardless of disease severity.

Regeneron 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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