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What Is the Current Status of AstraZeneca’s EUA Request for Their COVID-19 Monoclonal Antibody Shot as a Preventative for CLL Patients?

This content was current as of the date it was released. In science and medicine, information is constantly changing and may become out-of-date as new data emerge.

Ask the Doctor Question:

What is the status of AstraZeneca’s EUA request for their COVID monoclonal antibody shot as a preventative for CLL patients? If approved, would this be for pre-exposure use? Also, if AstraZeneca has had enough testing to get in front of the FDA for possible pre-exposure use, why is it that Regeneron is just starting a phase 3 trial that will run through 2023?

Answer: The status is still pending with the AZD7442 application still being reviewed by the FDA. And yes! It would be for preventative/pre-exposure use. From our understanding, EUA approval can take anywhere from a few weeks to a few months or even longer. There really is no way to tell until a broad announcement is made through the media. As soon as we hear anything, we will make sure and put something out about it on our website and our social media outlets, as this will be big news for those with CLL! If you haven’t already, please consider signing up for our weekly newsletter, as we will for sure include that breaking news there as well. You can do that here: https://cllsociety.org/newsletter-sign-up/.

As for your other question, we aren’t sure of the specifics surrounding the timing of Regeneron’s efforts. We can share that we have been in multiple talks with them over the past several months to advocate for them moving in the direction of doing a trial like this which is inclusive of the immunocompromised. So, we are extremely happy that they are now recruiting for this and that their trial will be so large.

We believe there are exciting things on the horizon when it comes to new COVID-19 preventative therapies/treatments. Stay tuned!