AZD7442 gets a name!

[bennevisplace]

Earlier this month Astrazeneca applied to the FDA for an emergency use authorisation (EUA) for its long-acting monoclonal antibody cocktail AZD7442. The application is based on the results of the PROVENT phase 3 trial of the drug as a prophylactic against Covid19, backed up by laboratory studies, purporting to show the drug's neutralising activity against the Delta and Mu variants, and safety data from the STORM CHASER trials.

More recently Astrazeneca has begun submitting data to the European Medicines Agency (EMA) under a "Rolling Review" arrangement. This is a fairly common way of fast-tracking a promising drug towards a formal marketing authorisation, but it tells us that some of the key data are not yet there. My guess is that EMA/ Astrazeneca want to have enough subjects monitored for 12 months to be able to demonstrate that protection is indeed "long acting" as billed. Another requirement could be confirming real-world protection against the Delta variant, which appeared circa mid 2021 in the PROVENT trial locations.

Oh, the name. Evusheld. Really. ema.europa.eu/en/news/ema-s...

[blowinginthewind]

Are people on W&W eligible for this - I was diagnose 3 1/2 years ago and I haven't had treatment yet. The form says "diagnosed in the last year" but that is very vague when it comes to us with our CLL.

[bennevisplace in reply to blowinginthewind]

I'm not sure what you mean by "The form says.."

The only monoclonal antibody treatment so far authorised for UK use is Ronapreve. This Evusheld is intended to be used as a durable (6-12 months) prophylaxis, pre-infection. It's not yet approved anywhere.

[blowinginthewind in reply to bennevisplace]

When I clicked the link on your post, it took me to information about who is eligible for the trial, and it said that it was for people diagnosed with cancer "with the last year" or who are having treatment or have had stem cell treatment. People with CLL on W&W for many years in some cases.

[bennevisplace in reply to blowinginthewind]

The link above is to the EMA website. Their article says nothing about a trial. I think you must have found that in another post. Maybe this one? healthunlocked.com/cllsuppo...

The PROVENT trial is listed as Active, not recruiting clinicaltrials.gov/ct2/show...