Regeneron seeks EUA for COVID-19 antibody as Trump vows to offer it for ‘free’

3
87

Regeneron has filed for FDA emergency use authorization (EUA) of its COVID-19 antibody cocktail. President Donald Trump, who obtained REGN-COV2 after catching the virus, mentioned he has “emergency use authorization all set” and can make the antibody cocktail obtainable for “free.”

In latest weeks, Regeneron and fellow anti-SARS-CoV-2 antibody developer Eli Lilly have revealed early medical proof of the effectiveness of their candidates. The info have provided encouragement that antibodies can sort out the coronavirus but in addition left unanswered questions in regards to the efficacy of the 2 main applications. It now appears unlikely these questions will cease the medication getting EUA.

Lilly and Regeneron revealed filings for EUA inside hours of one another this week. Regeneron mentioned it filed the EUA “subsequent to [its] discussions with regulatory authorities,” including that it has sufficient doses to deal with 50,000 sufferers and plans to deal with 300,000 sufferers throughout the subsequent few months.

Webinar

Contained in the COVID-SeroIndex – Assay Design and Efficiency

Be a part of a panel of consultants as they focus on the rigor concerned in optimizing and scaling a reproducible serological assay for COVID-19.

The back-to-back EUA functions got here shortly after Trump obtained Regeneron’s drug as a part of his remedy for COVID-19. Trump emerged from the expertise as a champion of the drug, hailing it as a “treatment.”

“I wasn’t feeling so sizzling. They gave me Regeneron. It was, like, unbelievable. I felt good instantly. I name {that a} treatment,” Trump mentioned throughout a speech outdoors the White Home. 

Trump additionally obtained the steroid dexamethasone and Gilead’s antiviral remdesivir, each of which may have contributed to the easing of his signs, however is satisfied REGN-COV2 was the driving power behind his restoration. That conclusion has turned Trump into an advocate of REGN-COV2. 

In addition to claiming “a whole lot of hundreds of doses … are nearly prepared,” regardless of Regeneron placing the determine of accessible doses at 50,000, Trump made an EUA sound like a accomplished deal and set out plans to make REGN-COV2 broadly obtainable to the U.S. inhabitants.. 

“I would like all people to be given the identical remedy as your president. I will make it free. You are not going to pay for it,” Trump mentioned.

Regeneron has a contract with the Biomedical Superior Analysis and Improvement Authority to produce the U.S. with a set variety of bulk a number of REGN-COV2. On the time of the deal, Regeneron mentioned the majority tons would cowl 70,000 to 300,000 doses of REGN-COV2, relying on how totally different doses carried out in medical trials. Trump mentioned the navy will deal with distribution, including that “that is straightforward stuff for them.”

3 COMMENTS

  1. Hi there! This post couldn’t be written any better! Reading through this post reminds me of my previous room mate! He always kept talking about this. I will forward this article to him. Pretty sure he will have a good read. Thank you for sharing!

LEAVE A REPLY

Please enter your comment!
Please enter your name here