Regeneron has asked the feds for an emergency approval of the experimental coronavirus drug that President Trump credits with helping him fight off the virus.
The New York-based biotech firm said it requested an emergency use authorization from the Food and Drug Administration for REGN-COV2, the so-called antibody cocktail meant to boost the body’s response to COVID-19.
Regeneron’s late Wednesday statement came as Trump touted the “unbelievable” drug in a five-minute Twitter video, saying he “felt good immediately” after his doctors administered the treatment last week.
Trump said he would support an emergency authorization for Regeneron’s antibody treatment and a similar drug developed by Eli Lilly, which said earlier Wednesday that it had asked the FDA for an emergency clearance.
News of Regeneron’s request sent its stock price soaring about 4.3 percent in premarket trading Thursday to $617.90 as of 7:17 a.m.
The emergency use authorization would make Regeneron’s drug more widely available to patients battling the coronavirus. The treatment is still going through clinical trials and is currently available to patients on a limited “compassionate use” basis.
If the emergency approval is granted, Regeneron said the feds would make the drug available for free and distribute doses to Americans. The company says it currently has doses available for about 50,000 patients and expects to have enough for 300,000 patients within the next few months.
Regeneron’s request came about a week after it released early data from its clinical trial showing the antibody drug helped people infected with COVID-19 shake their symptoms faster and reduced the amount of the virus in their bodies.
The FDA in May granted an emergency use authorization for remdesivir, another COVID-19 treatment developed by Gilead Sciences. Trump received a five-day course of the drug after he tested positive for the potentially deadly virus last week.
The FDA did not immediately respond to a request for comment about Regeneron’s emergency use request.
