Regeneron has filed for FDA emergency use authorization (EUA) of its COVID-19 antibody cocktail. President Donald Trump, who received REGN-COV2 after catching the virus, said he has “emergency use authorization all set” and will make the antibody cocktail available for “free.”
In recent weeks, Regeneron and fellow anti-SARS-CoV-2 antibody developer Eli Lilly have published early clinical evidence of the effectiveness of their candidates. The data have offered encouragement that antibodies can tackle the coronavirus but also left unanswered questions about the efficacy of the two leading programs. It now seems unlikely those questions will stop the drugs getting EUA.
Lilly and Regeneron revealed filings for EUA within hours of each other this week. Regeneron said it filed the EUA “subsequent to [its] discussions with regulatory authorities,” adding that it has enough doses to treat 50,000 patients and plans to treat 300,000 patients within the next few months.
The back-to-back EUA applications came shortly after Trump received Regeneron’s drug as part of his treatment for COVID-19. Trump emerged from the experience as a champion of the drug, hailing it as a “cure.”
“I wasn't feeling so hot. They gave me Regeneron. It was, like, unbelievable. I felt good immediately. I call that a cure,” Trump said during a speech outside the White House.
Trump also received the steroid dexamethasone and Gilead’s antiviral remdesivir, both of which could have contributed to the easing of his symptoms, but is convinced REGN-COV2 was the driving force behind his recovery. That conclusion has turned Trump into an advocate of REGN-COV2.
As well as claiming “hundreds of thousands of doses ... are just about ready,” despite Regeneron putting the figure of available doses at 50,000, Trump made an EUA sound like a done deal and set out plans to make REGN-COV2 widely available to the U.S. population..
“I want everybody to be given the same treatment as your president. I'm going to make it free. You're not going to pay for it,” Trump said.
Regeneron has a contract with the Biomedical Advanced Research and Development Authority to supply the U.S. with a fixed number of bulk lots of REGN-COV2. At the time of the deal, Regeneron said the bulk lots would cover 70,000 to 300,000 doses of REGN-COV2, depending on how different doses performed in clinical trials. Trump said the military will handle distribution, adding that “this is easy stuff for them.”