Trump Touts Unproven Therapy as COVID ‘Cure’
Early study data shows that the Regeneron therapy is safe and has few side effects, according to CNN. Human clinical trials began in June, and late-stage trials started in July. Some scientists are awaiting more data and a peer review to decide how well the drug works.
“I would withhold judgment on this until we see the data,” Richard Besser, former acting director of the CDC and now head of the Robert Wood Johnson Foundation, told CNN.
“You know these early results that keep coming out from companies in press releases strike me as being … much more about the stock price than they are about science,” he said.
At least 70 other COVID-19 antibody treatments are being tested. Among those, Eli Lilly also submitted a request to the FDA on Wednesday for emergency use authorization of its single monoclonal antibody therapy. The company expects to submit an application for its combination therapy in November.
The company could have 100,000 doses available this month and 1 million doses ready by late December, according to CNN.
“Our expectation is that there shouldn’t be a cost to patients,” Daniel Skovronsky, MD, the chief scientific officer for Eli Lilly, told CNN on Wednesday.
Alongside the requests for FDA emergency use authorizations, both companies will continue to study the antibody therapies in large clinical trials, which will provide better data on safety and how well the treatments work.
“Randomized clinical trials to answer these questions are now a priority,” Martin Landray, PhD, an epidemiologist at the University of Oxford, told the Science Media Centre in the U.K.
There is a “way to go” before the data shows whether these antibody drugs can effectively reduce severe forms of COVID-19, he said. This requires important data on hospital admissions, the length of hospital stays, the need for mechanical ventilation, and survival rates among coronavirus patients.
“It is encouraging to see that both Eli Lilly and Regeneron have active plans for much larger trials in a range of different settings, including residential care homes, outpatients, and hospital inpatients,” Landray said.