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1123 Regeneron EUA
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Regulation

Distribution of Regeneron’s COVID-19 antibody cocktail to begin Tuesday 

Nov 22, 2020 | 2:44 AM GMT

Starting Tuesday, distribution of Regeneron’s antibody cocktail for COVID-19 will begin via an existing network of hospitals and associated facilities, with plans for a subsequent expansion that will include a broader range of outpatient centers.

At a press briefing Monday, Operation Warp Speed officials said the first 30,000 doses of casirivimab/imdevimab (REGN-COV2) from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) will be allocated to states, territories and agencies.

FDA granted an emergency use authorization on Saturday for the mAb combination. The EUA covers outpatient use only in patients with mild to moderate disease who are at high risk of progression to more severe COVID-19, including patients 65 and older and those with chronic medical conditions.

Although it will be distributed initially to hospitals, the therapy will reach patients at other facilities such as urgent care centers, nursing homes and newly created pop-up distribution centers.

John Redd, HHS's CMO in the Office of the Assistant Secretary for Preparedness & Response, said at the briefing that distribution of Regeneron’s product will mirror initial distribution of the other therapeutic mAb approved for COVID-19, bamlanivimab from Eli Lilly and Co. (NYSE:LLY) and AbCellera Biologics Inc. That product has been delivered to 85,000 patients at nearly 2,500 care sites since FDA granted its EUA on Nov. 9. A single Operation Warp Speed playbook describes distribution of both treatments.

Regeneron is rapidly building supply of its cocktail, and said Saturday it will have doses for 80,000 patients by the end of November. By the first week of January, the company believes it will be able to reach 200,000 patients; its expectation grows to 300,000 by January's end.

Phase II data released last month showed that IV infusions of casirivimab/imdevimab reduced COVID-19-related medical visits by 57% through day 29 overall, and 72% in patients with one or more risk factor.

Recommendations from an independent DMC in late October suggested the optimal window for therapeutic antibodies’ use may be earlier in COVID-19’s course.

Weekly allocation to states and territories will be based on an analysis of two factors: the number of hospitalizations and the total number of COVID-19 cases in each place. Redd said the methodology is designed to identify hot-spots, and account for a lag between the number of cases and hospitalizations.

The methodology is also the same as that used to distribute Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD), the only COVID-19 treatment that FDA has approved.

In July, Operation Warp Speed reached a deal with Regeneron to secure up to 300,000 doses of the mAb treatment for $450 million.

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