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Thursday, Oct 8 2020

Full Issue

Regeneron Applies For Emergency FDA Approval Of Antibody Cocktail Given To Trump

Regeneron submitted an application to the FDA for emergency use authorization of REGN-COV2, its experimental monoclonal antibody coronavirus therapy. The biotech says it only has enough doses now for 50,000 people currently and that the government would be responsible for distribution.

Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus. The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night. (Erdman, 10/8)

The news of Regeneron鈥檚 application on the same day that Mr. Trump effusively praised the unproven drug is likely to intensify fears that the president is pressuring federal health agencies to make decisions aimed at benefiting him politically. In the video, Mr. Trump repeated his desire to get a vaccine approved before the election, even though the vaccine makers themselves have said that is highly unlikely. (Thomas, 10/7)

The biotech company published a statement Wednesday noting that 鈥渋f an EUA is granted the聽 government has committed to making these doses available to the American people at no cost and would be responsible for their distribution.鈥 At this time, there are doses available for approximately 50,000 patients, Regeneron said, 鈥渁nd we expect to have doses available for 300,000 patients in total within the next few months.鈥 (Ellyatt, 10/8)

Also 鈥

Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc, and on Wednesday he promised to make it free to Americans while touting its benefits. Medical experts said more data is needed to assess the treatment鈥檚 efficacy before wider use should be allowed. (Beasley, 10/7)

This week, President Donald Trump extolled the cutting-edge coronavirus treatments he received as 鈥渕iracles coming down from God.鈥 If that鈥檚 true, then God employs cell lines derived from human fetal tissue. The emergency antibody that Trump received last week was developed with the use of a cell line originally derived from abortion tissue, according to Regeneron Pharmaceuticals, the company that developed the experimental drug. (Regalado, 10/7)

On Friday morning, President Trump received an experimental treatment for Covid-19 developed by Regeneron. At the time, it had only been provided to fewer than 10 patients outside of clinical trials, under聽 so-called compassionate use. Data for the drug had been presented for the first time earlier that week on a company conference call. It was, to put it mildly, an unusual situation. (Herper, 10/8)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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