Regeneron Antibody Cocktail Cuts Hospitalization Rate by 70%
(Bloomberg) -- Regeneron Pharmaceuticals Inc. said it would apply for U.S. authorization for a lower dose of its Covid-19 antibody cocktail, after data from a final-stage trial showed early use of the drug reduced hospitalizations and deaths by 70%.
The Food and Drug Administration in November cleared Regeneron’s therapy for emergency use. The treatment is part of a class of therapies that were widely hailed for their effectiveness, though the drugs have been slow to be widely adopted because they are difficult to administer.
The treatment was studied in a phase 3 trial involving 4,567 people infected with the coronavirus who were at high risk of developing severe disease.
Those who were given the authorized dose of 2,400 milligrams had a 71% lower risk of hospitalization or death, compared with those who got a placebo, Regeneron said in a statement. But the trial also found that half the authorized dose, or 1,200 milligrams, was nearly as effective, lowering hospitalizations and deaths by 70%.
“We will rapidly discuss the new data with regulatory authorities and request that the 1,200 mg dose be added” to the U.S. emergency authorization, George Yancopoulos, Regeneron’s chief scientific officer, said in a statement.
Authorization of a lower dose level would allow Regeneron to produce more doses of the treatment faster. The company previously said it expects to produce about 750,000 doses by the end of the second quarter, based on the 2,400-milligram dose.
“If the dose goes down, the same volume of manufacturing will produce more doses,” spokeswoman Alexandra Bowie said.
Roche Holding AG, Regeneron’s partner on the cocktail, is working outside the U.S. to try to get the drug combination approved by regulators such as the European Medicines Agency. Roche Chief Executive Officer Severin Schwan said in February capacity for the cocktail would be about 2 million doses this year.
Regeneron’s antibody cocktail was given to former President Donald Trump after he came down with the coronavirus in October. It received emergency clearance based on initial trial results in roughly 800 outpatients showing it reduced virus levels and the need for further medical visits.
In February, Regeneron said that the results from the phase 3 portion of the study had found clear efficacy in reducing hospitalizations and deaths at both doses studied, but it hadn’t released details.
In the phase 3 study, the drug cocktail “met all secondary endpoints” including the ability to reduce symptom duration, the company said. In both doses studied, the duration of symptoms was reduced by four days, from 14 days to 10 days. No new safety issues were identified in the trial, the company said.
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