HHS Begins Distribution of Regeneron’s COVID-19 Antibody Treatment

Regeneron has won Emergency Use Authorization (EUA) from the FDA for its investigational antibody cocktail for the treatment of patients with mild-to-moderate COVID-19 symptoms at high risk of severe disease progression or hospitalization — and an initial 30,000 doses are expected to ship today.

The cocktail, a combination of two monocloncal antibodies derived from the plasma of recovered CODID-19 patients, was supported by positive phase 2/3 data that showed the treatment significantly reduced the number of medical visits needed by 800 nonhospitalized COVID-19 patients (DID, Oct. 30).

The monoclonal antibodies, casirivimab and imdevimab, mimic the body’s immune function to block the COVID-19 spike protein from invading healthy cells. The New York-based drugmaker said the treatment has the most benefit “when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.”

Regeneron CEO Leonard Schleifer said demand may exceed supply initially, making it “even more critical that federal and state governments” ensure the cocktail is “distributed fairly and equitably to the patients most in need.”

To boost supply, HHS is asking recovered COVID-19 patients to donate plasma if they are within three months of infection. To scale up production, the biotech firm forged a partnership in August with Roche and has said it expects to treat approximately 300,000 patients in the U.S. by the end of January 2021.

State health departments will handle on-the-ground distribution to hospitals and outpatient clinics, HHS said. To ensure effective administration of the intravenous therapy, health departments must evaluate facilities based on available quarantine space and whether health staff is sufficiently trained and has the necessary equipment.

There is currently no federal guidance for determining who receives the treatment first, so for now health departments are expected to prioritize high-risk populations, such as patients 65 years or older. ― Jason Scott