Response from the FDA re Regeneron

[CBME]

This is part of the response I received from the FDA when I asked when the Regeneron Monoclonal Antibody cocktail will be available for use as a preventative in people who are immunocompromised such as with CLL. I have just included the information for the request of expanded use and not their entire response as it was very long. Thank you to the member who provided the information of sending questions to the FDA. It worked. It is good information.

Here is what they said:

REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus. If your physician feels that you are a candidate for pre-exposure prophylaxis, please ask your physician to reach out to FDA to request expanded access. Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

You may provide this information to your physician in case he/she is unfamiliar with the process:

Expanded Access | FDA

Expanded Access | Information for Physicians | FDA

If you or your physician would like to speak to our staff about the process, please feel free to reach out to us at 301-796-3400.

Best Regards

HT

Pharmacist

Division of Drug Information

Center for Drug Evaluation and Research

Tel: 855-543-DRUG (855-543-3784)

[ikahan]

I think all hem-onc docs should start bombarding FDA with requests for expanded access to REGEN-COV mAbs for pre-exposure prophylaxis for their CLL patients. I don't understand why FDA and Pharma are dragging their feet in starting clinical trials in this area.The 3rd booster shot does not appear to work very well for those that had zero response tothe vaccines

[CBME in reply to ikahan]

Agreed.

[johnl]

Did they say if pre-exposure prophylaxis use approval for imuno compromised was even being studied or considered?

john

[CBME in reply to johnl]

No. They just said your doc could apply for the preventative use. They didn’t say they were considering it. What I did was got a home COVID test $23 at the drug store, then I called my local hospitals and talked to the emergency room and found out which hospital has the monoclonal antibody cocktail so I would know where to go if I get sick.

[4Glory]

Hi, was this before or after the "expanded use" directive from a couple of weeks ago? According to that, if I just visit a jail, I should be able to get them. My cancer hospital is uninterested in all of these things.

[DRM18 in reply to 4Glory]

“My cancer hospital is uninterested in all of these things”—lol!

(I can relate!)