"Regeneron Pharmaceuticals Inc. said its antibody drug reduced the risk of Covid-19 hospitalization or death by about 70% in a large clinical trial, the most definitive evidence yet that the medicine can aid recovery early in the course of disease.
Among subjects in a late-stage trial receiving a lower dose of the antibody drug, 1% were hospitalized or died, compared with 3.2% of patients receiving placebos, Regeneron said Tuesday. Study subjects getting a higher dose had a similar risk reduction, the company said.
Regeneron said it would seek FDA authorization for the lower dose after it proved similarly effective to the higher dose currently available. The change would effectively double manufacturing capacity of the medicine going forward. The data haven't yet been published in detail or in a peer-reviewed journal.
Regeneron's drug is among a handful of therapies authorized for Covid-19 patients to prevent severe disease and hospitalization. The drugs are targeted at patients early in the disease, when the virus is thought to be most susceptible to treatment.
The therapies have been scantily used, however, because of what doctors say is a cumbersome process for administering them and a lack of robust clinical trial data proving their effectiveness.
The new study data released by Regeneron on Tuesday could help boost enthusiasm for the medication among doctors and hospitals. The data could also eventually prompt influential expert panels convened by the National Institutes of Health and the Infectious Diseases Society of America to issue treatment guidelines recommending the drug's use.
In November, the U.S. Food and Drug Administration cleared Regeneron's drug and another antibody treatment made by Eli Lilly & Co. for treating people with mild or moderate symptoms of Covid-19 who are at high risk of developing severe cases." [1]
1. Antibody Drug Cuts Risks, Study Says
Walker, Joseph. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]24 Mar 2021: A.6.
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