Regeneron antibody cocktail lowers hospitalisation rate by 70%

[NEW YORK] Regeneron Pharmaceuticals Inc said it would apply for US authorisation for a lower dose of its Covid-19 antibody cocktail, after data from a final-stage trial showed early use of the drug reduced hospitalisations and deaths by 70 per cent.

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 authorised dose of 2,400 milligrams had a 71 per cent lower risk of hospitalisation or death, compared with those who got a placebo, Regeneron said in a statement. But the trial also found that half the authorised dose, or 1,200 milligrams, was nearly as effective, lowering hospitalisations and deaths by 70 per cent.

"We will rapidly discuss the new data with regulatory authorities and request that the 1,200 mg dose be added" to the US emergency authorisation, George Yancopoulos, Regeneron's chief scientific officer, said in a statement.

Authorisation 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.

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 hospitalisations 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.

BLOOMBERG