It’s no secret President Trump was one beneficiary of Regeneron’s boundary-breaking antibody cocktail after it was administered to him in October. A month later, the drug again made headlines when it was granted an Emergency Use Authorization by the U.S. Food and Drug Administation. According to Hannah Kwagh, senior manager of product and pipeline communications at Regeneron, the drug is already well on its way to being available to the public.
“Clinical trials of our antibody cocktail are actively recruiting in multiple populations…, with more than 7,000 people participating in the clinical program to date,” explains Kwagh of the drug, which combines the antibodies casirivimab and imdevimab. “We have received an Emergency Use Authorization from the FDA for certain mild-to-moderate, high-risk patients, and the U.S. government has begun providing the initial 300,000 doses at no out-of-pocket cost to patients.”
Kwagh notes that doses will have been ready for approximately 80,000 patients by the end of November, adding that “200,000 doses in total will be ready by the first week of January and approximately 300,000 total doses will be ready by the end of January 2021.” She also says Regeneron has continued to increase its in-house production, partnering with Roche to substantially expand capacity in 2021, when the company expects to produce at least two million doses of the treatment per year.
Despite the recent, positive news regarding Moderna’s and Pfizer’s coronavirus vaccines, Regeneron still sees itself playing a vital role in treatment programs ahead. “Even once we have a well-proven and widely available vaccine, there will remain a need to treat infected patients and others who may not have access to or were not protected by vaccination,” says Kwagh. “Both vaccines and antibody medicines are important and necessary to combat the COVID-19 pandemic, and it’s been gratifying to see the progress made by our industry in record time on both fronts.”
In a November 21 statement, Regeneron president/CEO Len Schleifer cautioned that the drug’s recent authorization does not mean studies on its effectiveness and safety are over. “[Emergency Use Authorization] allows certain patients in need to access this promising investigational therapy, but I want to be clear that much of the work still lies in front of us,” Schleifer stated. “We must complete our well-controlled clinical studies as quickly as possible in order to provide conclusive answers on the full safety and efficacy profile of casirivimab and imdevimab. And we must work to continue rapidly scaling up additional supply, including through our collaboration with Roche, which will more than triple total manufacturing capacity.”