Preventive monoclonal antibodies

[krperez]

I got this information from someone and thought others would be interested:

There is an FDA website on which one can write to the FDA about approving use of the monoclonal antibodies to help prevent COVID among the immune-compromised. We could try to inundate the FDA with questions as to why they have not granted EUA for the prophylactic use of the monoclonal antibodies for those in our situation. Back in April, Regeneron supposedly applied back in April of this year: "Regeneron will request.....EUA expansion to include COVID prevention for appropriate populations, using a 1,200 mg subcutaneous dose." (April 12,

2021)

The form to use to ask questions of the FDA is at the following site: accessdata.fda.gov/scripts/...

We’re probably all familiar with the squeaky wheel etc. It is important to stress that there are 10,000,000 Americans who are immunosuppressed without a response to any Covid-19 vaccine, and that we too, must be able to return to our lives and livelihoods. I’m going to submit my request and thought perhaps others with MPNs who feel they themselves or others they know are at high risk of getting COVID might want to do the same.

Hoping for the best,

Karni

CLL dx 2003, F/R in 2008

On ibrutinib since 2013

[Belfastbees]

Karni, I see you are in the US where money talks but in the UK I think there was a trial which returned the use of monoclonal antibodies as limited. This was as treatment after infection though, and not as a prophylactic prior to exposure or potential infection, I'm not aware of any study into that which may well be different. I don't think it's likely to be fast tracked in UK, or given any emergency approval.

[bennevisplace in reply to Belfastbees]

In UK I think EUA is n.a. and no Covid-mAb provider has submitted an application to MHRA.

2nd generation mAbs from AZ and GSK are still in trials, though GSK had enough data for recent approval of Sotrovimab by EMA.

We live in hope.

[bennevisplace]

REGEN-COV has EUA as "prophylactic" in limited circumstances, see

healthunlocked.com/cllsuppo...

[Dancedunce]

Hi Karni, I sent my question in about expedition of the Regeneron monoclonals. Thanks so much for your advocacy.

[CBME]

I sent my question in also.