President Trump’s endorsement of an experimental Covid-19 drug from
Regeneron Pharmaceuticals Inc.
has raised expectations for a type of medicine that could be authorized for public use within weeks or even days.
Regeneron is racing against rival
Eli Lilly & Co.
to bring the first monoclonal antibody drug on the market to treat Covid-19 patients who aren’t sick enough to be hospitalized. Both companies said Wednesday they had asked the U.S. Food and Drug Administration to authorize use, and they had already made tens of thousands of doses for patients.
If greenlighted, the shots would begin to fill a big hole in the Covid-19 medicine chest for treatment of early and less-severe cases. After more testing, they could offer temporary protection against infections until vaccines arrive. But supply is unlikely to meet demand until next year at the earliest.
Monoclonal antibodies, which are also used to treat cancer and other diseases, take a page from the body’s own soldiers for fighting pathogens. Both Lilly and Regeneron researchers derived their drugs from naturally occurring Covid-19 antibodies.
Each of the companies has released encouraging data from early-stage clinical trials showing their drugs helped reduce coronavirus levels and improve symptoms in patients not sick enough to be hospitalized. Lilly and Regeneron have already started studies to see if their antibody drugs can prevent Covid-19.
Given the urgent need, the companies asked the FDA to use a special review process reserved for emergencies such as pandemics and authorize use before the therapies have finished all the stages of testing normally required for approval.
The FDA could issue the go-ahead for the monoclonal antibody drugs as soon as Friday, SVB Leerink analyst Geoffrey Porges said. The agency could feel comfortable making a quick decision, he said, because it is already familiar with the way antibody drugs work, having approved many of them over the years to treat other diseases.
The FDA declined to comment about its review of the applications or the timing of a decision.
The agency has granted emergency-use authorizations for two therapies for hospitalized Covid-19 patients, the antiviral remdesivir from
Gilead Sciences Inc.
and antibody-rich convalescent plasma taken from recovered coronavirus patients. An antibody drug could be the next agent to be permitted for use.
Last Friday, Mr. Trump was given a high dose of Regeneron’s drug, code-named REGN-COV2, under a program that allows patients to take experimental drugs outside of clinical trials. He was later given the antiviral drug remdesivir, which the FDA authorized in May, and the already approved steroid dexamethasone.
Mr. Trump’s doctors have said he is symptom free. In a video released late Wednesday, the president attributed his return to health to Regeneron’s drug.
“They gave me Regeneron, and it was like, unbelievable. I felt good immediately,” he said. Independent doctors