Regeneron and Roche's REGEN-COV Antibody Cocktail Reduces Hospitalization and Death Risk by 70% in High-Risk Non-Hospitalized COVID-19 Patients

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Regeneron and its partner Roche have announced new Phase III clinical data demonstrating that their therapy can both treat infected patients and provide protection for unvaccinated individuals. Analysts estimate that, pending regulatory approval, the antibody cocktail REGEN-COV held by these two companies will become a blockbuster product.

REGEN-COV consists of two monoclonal antibodies, casirivimab and imdevimab. According to joint announcements, REGEN-COV reduced the risk of hospitalization or death by 70% in high-risk non-hospitalized patients compared with placebo. Importantly, REGEN-COV retained efficacy against five major SARS-CoV-2 variants, including those originating from South Africa, the United Kingdom, and New York. Furthermore, REGEN-COV was effective at three different dose levels.

In November 2020, REGEN-COV was granted Emergency Use Authorization (EUA) by the U.S. FDA. The agency stated that it was currently the only antibody therapy available to combat new variants. Supported by the newly released data, Regeneron plans to request that the FDA update its guidance to include the lowest dose of 1,200 mg tested in the Phase 3 clinical trials.

However, REGEN-COV also faces competition from Eli Lilly’s antibody cocktail. In another Phase 3 clinical trial, the antibody cocktail therapy composed of two monoclonal antibodies, bamlanivimab and etesevimab, reduced the risk of hospitalization and death by 87% in high-risk patients with early-stage infection. Previously, this antibody cocktail therapy also received Emergency Use Authorization (EUA) from the U.S. FDA for the treatment of high-risk patients.

Roche and Regeneron emphasized the relevance of the latest clinical trial results in protecting high-risk populations from COVID-19 and emerging viral variants. All patients enrolled in this Phase 3 clinical trial had at least one risk factor that could lead to severe complications from the virus. For example, nearly 60% of the patients were obese, more than half were over 50 years old, and 36% had cardiovascular disease.

Suraj Saggar, Medical Director of Infectious Diseases at Holy Name Medical Center in Teaneck, New Jersey, and an investigator in the trial, stated in a press release, “Given the high number of ongoing infections and recent data demonstrating REGEN-COV’s efficacy against new variants, these findings underscore the need to rapidly adopt REGEN-COV as the standard of care, offering high-risk patients the best opportunity to reduce severe outcomes such as hospitalization or death.”

Regeneron stated that it expects sales of REGEN-COV in the U.S. market to reach $260 million in the first quarter of this year. On Tuesday, analysts at U.S. investment bank SVB Leerink issued a report to clients, estimating that sales of this antibody cocktail therapy could reach $2.6 billion in the second quarter. Last autumn, Karen Andersen, an analyst at the internationally renowned rating agency Morningstar, indicated that REGEN-COV might achieve $6 billion in sales in 2021, a figure twice her projected peak sales for Gilead’s antiviral drug remdesivir.

Under the collaboration between Regeneron and Roche, Regeneron is responsible for development and commercialization in the U.S. market, while Roche handles markets outside the United States. Currently, the European Medicines Agency (EMA) is conducting a rolling review of this antibody cocktail; however, in February, the agency stated that the drug could be used to treat high-risk patients with severe progressing COVID-19 prior to the completion of the review. In a statement, Roche indicated that data from the Phase 3 clinical trials have been shared with regulatory authorities worldwide.

However, given that vaccine supplies are set to increase substantially in the coming months, is there still a global need for COVID-19 therapeutics? Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, pointed out that 3 million new COVID-19 cases were reported worldwide last week. Thus, there is a market for the antibody cocktail, “particularly in light of recent evidence showing that REGEN-COV retains activity against major emerging variants.”

Currently, other clinical trials of REGEN-COV are underway worldwide, including a Phase 3 trial in the United Kingdom treating hospitalized COVID-19 patients, and a preventive trial among household contacts of COVID-19 patients, to evaluate the therapeutic and prophylactic effects of REGEN-COV.

Source: Regeneron, Roche COVID-19 antibody cocktail slashes hospitalizations and tackles variants in phase 3