Emergency use authorization of a new pre-exposure prophylaxis (PrEP) for COVID-19, PEMGARDA™ (VYD222)

[bkoffman]

Hi,

Great news for the immunocompromised community including us. Invivyd announced late last week the emergency use authorization of their new pre-exposure prophylaxis (PrEP) for COVID-19, PEMGARDA™ (VYD222).

It’s a one-hour infusion and lasts 3 months and based on titers should be effective against the present VOC of SARS-CoV2. And it was studied in the immunocompromised! It does have a 0.6% risk of anaphylaxis so discuss with your healthcare team but this is great news overall for CLL patients.

Here is the link to the press release: investors.invivyd.com/news-...

Here is the link to the patient fact sheet: invivyd.com/wp-content/uplo...

This makes me happy because as we know for CLL/SLL patients protection from vaccines is incomplete and now we have another prevention option similar to EVUSHELD when it was effective.

CLL Society will be posting more information on our website very soon.

Stay strong.

We are all in this together.

Brian

Brian Koffman MDCM (retired) MS Ed

Co-Founder, Executive VP and Chief Medical Officer

CLL Society, Inc

cllsociety.org

[elm1]

thanks for that!!

[JigFettler Volunteer]

Thanks Brian! All best wishes to you!

Jig

[Peggy4]

That’s good news. Thanks for the info Brian. I presume this is USA only for now?

Here in UK we seem to also be in a measles epidemic!

Peggy

[CLLerinOz Administrator]

This excellent news is generating great interest, Brian, and those of us outside the US hope that Pemgarda might become available in some other countries before too long, too, although some of us have bad memories of the delays and failure to provide Evusheld in places like Australia and the UK. Here’s hoping, nonetheless.

Have you any information you can share about how ‘Evusheld 2.0’ AZD3152 is progressing?

For those interested, here are some other discussions in our community on the topic of Pemgarda’s recent emergency use authorization (EUA):

healthunlocked.com/cllsuppo...

healthunlocked.com/cllsuppo...

healthunlocked.com/cllsuppo...

CLLerinOz

[johnliston]

Brian, I'm in the Supernova trial. Have you heard anything about the approval of this new Evusheld, and have you heard anything about how these two drugs compare with each other? Is one more effective than the other, does one have fewer side effects? To me a shot of the new Evusheld every six month is a lot better than an infusion every three.

john

[Eucalyptus22]

I too am on the Supernova trial and understand that the results are being presented by AZ in Barcelona on 28th April. There is an expectation that Canada and USA are going to go to Emergency Use Authorisation shortly after that. I also understand that here in the UK the MHRA and NICE are currently looking at the data in parallel. Who knows what decision they will make?

Kate