Any news about authorisation of the preventative antibody treatment from the PROVENT study?

https://forum.bloodcancer.org.uk/t/access-to-nmabs-antivirals/4905/325?u=mca

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Latest news on Evusheld

Https://www.astrazeneca.com/media-centre/press-releases/2022/evusheld-significantly-protected-against-symptomatic-covid-19-for-at-least-six-months-in-provent-phase-iii-trial-in-high-risk-populations1.html

Lets do our own thing Government attitude stinks.

Note within the reference to BA2.

Please everyone get on the phone to your MP, emails largely ignored.

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Hi all, please see our latest blog regarding Evusheld which also links to our template MP letter - Our position on Evusheld | Blood Cancer UK

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Thank you for the update. Have used your template to email our MP.:slightly_smiling_face:

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Within BCuk letter to MP there is a link to data relating to effectiveness of Evusheld in comparison to other monoclonal antibodies.

I understand the Government are not convinced by such data.

However i am still puzzled as i thought Evusheld was meant as a preventative measure not a cure.

After all it does not preclude the receipt of the current treatments as far as i am aware should you be unfortunate and get Covid.

As this is somewhat unique product surely the proof of its ability to be preventative is by testing it on real people, rather than in the lab.

Such tests at least on mice, seem to point to success in that respect. See data from AZ posted earlier.

SURELY IF people can not get it in uk we will never know how effective it is in a preventative role.

I for one am happy to act as a guinea pig.

Basically i would like to know is the lab testing is being applied appropriately in respect of Evusheld as a preventative medicine rather than a cure.

After all the vaccination hardly has prevented covid spread especially in relation to omicron. Notwithstanding that it gives many no protection on any front.

So unless the government can proove scientificly Evusheld has no preventative benefit to the Immunosuppressed it appears they are barking up the wrong tree?

I would welcome a more informed view.

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@MCA I think you have hit on an important point about the way the data are being analysed in respect of Evusheld. As far as I am aware the efficacy of covid vaccines are not being directly compared with that of covid treatments. The reason is fairly obvious - vaccines are intended to prevent you catching covid, or at least to avoid you becoming seriously ill. Evusheld fulfils a similar role for those for whom vaccines don’t work, yet its efficacy seems to be being compared directly with treatments, presumably because they happen to use the same technology - i.e. monoclonal antibodies. For some reason, the faulty logic of this comparison, which isn’t applied to vaccines, is being missed.
Psychologically, the difference between a prophylactic and a treatment is massive, which is why Evusheld, like the vaccine, would be for most immunocompromised people, a game changer. If you were caught in the crossfire of a gun battle, would you rather be handed a bullet proof vest or a phone with which you could call on a medical team, should you get hit? I think most people would take the vest, though it wouldn’t be unreasonable to expect both. In this pandemic, those for whom the vaccine works, have access to both excellent prevention and to efficacious treatments. Surely it is not too much to ask that the immunocompromised enjoy the same?

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@davecpep

Dave looks like you and me will be the volunteers I’m happy to test a flac jacket even if it may have armholes. :crazy_face::beer:

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I have found a few articles online via twitter and found one stating that “Evusheld is currently at the Marketing Authorisation stage” It lists all the stages it still needs to go through as Initial pricing decisions, NICE agreement to price, NICE deciding if it will pay for it and who can have it.

From a previous personal experience in waiting for NICE to agree to pay for a drug in the past I would assume this will take quite some time.

I have also seen reports on Twitter where people have had replies from MPs saying it will be ordered shortly but i am not sure if this can be trusted.

Hopefully something more concrete will be said shortly.

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Please find a link to BBC South News today which has a segment on Evusheld , featuring Juliet Coffer, a sarcoidosis patient, and myself as a lymphoma (and kidney disease) patient , pressing for the rollout of it.

Evening News - The link should work until 6.30pm tomorrow BBC iPlayer - South Today - Evening News: 19/05/2022

Late News (slightly different and shorter clip) - the link should work until 10.35pm tomorrow BBC iPlayer - South Today - Late News: 19/05/2022

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@CaroleCW

Well done on getting the message out there and getting BBC interested.

I too have NHL namely WG and also after treatment Hypogammaglobulinemia, i.e have below normal antibody levels, and no measureable vaccine response.

Like you i have have endured the last two plus years and the similer restrictions upon my life and what you said rang so true to me. I have never spoken to anyone similerly effected so to just hear someone say what i have been telling all and sundry was a wellcome tonic.

I think you know where i stand, keep up the good work.

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Thanks MCA , yes just feeling we are not alone and that others are going through the same thing goes a long way to helping get through this period.

Am hopeful my immune system will produce some antibodies sometime soon (none after the first 4 jabs but I am now 15 months out of treatment) or that Evusheld or a similar preventative alternative to the vaccine will come along before too long.

Stay safe and well

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Well done you, keep pushing. Funny that commercial sensitivity didn’t seem to come into it when the Govt announced in autumn 2020 that they had procured 1 million doses of AZD7442 (the original name for Evusheld before it got its brand name), and again when they cancelled the order in May/June 2021.

Astra Zeneca have also said in their response to @AdrianWarnock that they are not concerned from a commercial sensitivity perspective with regard to Evusheld and potential U.K. Govt procurement.

This is just continued obfuscation on the matter of Evusheld by this Govt in my view

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I came across a more recent study suggesting Evusheld works against BA2

https://www.nejm.org/doi/10.1056/NEJMc220193

I think this adds weight to the one linked to your draft letter to MP,s.?

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Hello @MCA, could you re-send this link as it says ‘404 page not found’ when I click on it. Many thanks Gemma

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Here’s another positive study about Evusheld efficacy and Omicron Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the Omicron wave

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And here’s Evusheld efficacy results vs Omicron in blood cancer patients - note less efficacy in the cohort originally given 150mg dosing level, the US then increased dosing to 300mg level which increased efficacy for 9/10 patients. (US standard dosing for all is now the increased amount for all immunocompromised)

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Well the question was asked, meaning that Evusheld has now been raised on both sides of the house which I guess is progress. Johnson’s answer was predictably non-commital of course, acknowledging the drug’s potential but saying “ … we need to look at the available evidence”.

Same old. Doesn’t sound like it’s happening anytime soon :confused:

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The BBC have apparently contacted Graham Stuart since PMQs with a view to doing a piece on Evusheld , all good for adding further momentum

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@MCA @GemmaBloodCancerUK @davecpep

See this link Evusheld long-acting antibody combination retains neutralising activity against Omicron variants BA.4 and BA.5, according to new study from University of Oxford

Study by Univ of Oxford showing Evusheld efficacy against BA4 and BA5 variants, hooray!

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