HC device petition

HC device petition

Postby Pat » Wed Jan 30, 2019 10:35 am

Hi everyone, one of our members has a petition for an easier style hydrocortisone emergency injection. More details here https://you.38degrees.org.uk/petitions/for-cortisones-sake-give-steriod-dependents-the-life-saving-injection-they-need

thanks, Pat
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Re: HC device petition

Postby Carl » Thu Jan 31, 2019 1:03 pm

Thanks Pat, I saw this on Facebook and have already signed, but good to have it here too. Let's hope we get one, one day :)
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Re: HC device petition

Postby KitKat » Wed Feb 06, 2019 3:35 pm

Hi Carl,

There is a prototype hydrocortisone auto injector ready to go, the Crossject Zeneo. It has been developed by a French company.
https://www.crossject.com/en/zeneor-pro ... technology
Anecdotally, I learn that it got dinged by the European Medicines Agency when it applied for orphan drug designation, on two grounds:
1. They couldn't see why it is superior to the existing Solu-Cortef Act-o-Vial or why there would be patient demand for it. (Aargh!)
2. Adrenal insufficiency is not rare enough as an umbrella condition to meet the upper threshold for a rare disease. Any of the underlying conditions causing adrenal insufficiency, eg pituitary or CAH on its own, would qualify. But combined, they are not a 'rare disease' within the EC definition.
The ceiling for a rare disease within the EMA's regulatory area is 1 in 2000 or 500 per million. There is a distinct UK definition o0f <30,000 for the UK as a whole. Adrenal insufficiency from all causes notches up about 600 per million in recent studies, although older studies would put it below that threshold. If you excluded secondary suppression from prior steroid use and only looked at primary from autoimmune, CAH, surgical removal etc, plus secondary from pituitary conditions, then it might still be below the rare disease cutoff – but it's not clearcut and you might have to semantically exclude some types of pituitary condition. Sigh.
So Rachel's petition could help support an appeal to EMA to reconsider its rejection of the Crossject Zeneo auto injector. As a warning, the Zeneo is single use and likely to cost upwards of £70 a pop, so it's likely to be reserved for paediatric use and in adults, those with poor eyesight, peripheral neuropathy or other complications that mean self-injection isn't feasible. But still worth fighting for, because it will save lives.

Best
Katherine
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