The European rollout of Diurnal's adrenal franchise is well underway with the availability, in most markets, of Alkindi - a child-friendly hydrocortisone presentation - and now Efmody - a hydrocortisone preparation that mimics the normal physiological release of hydrocortisone. Alkindi is approved for paediatric adrenal insufficiency, including congenital adrenal hyperplasia (CAH), while Efmody is approved for the treatment of adults and adolescents with CAH. With both available, Diurnal now offers improved treatment options for the continuum of patients with adrenal insufficiency, including CAH, from childhood through to adulthood.
The commercialisation of the adrenal franchise in Switzerland started with EffRx and the approval of Alkindi by Swissmedic in 2021. The announcement today extends that agreement to include Efmody. As part of the agreement, EffRx will seek regulatory approval in Switzerland using the clinical data submitted by Diurnal as part of the EMA approval. Submission of the MAA for regulatory review by Swissmedic is expected during H2 2022 with regulatory approval anticipated in 2024. According to the release, there are circa. 450 CAH patients in Switzerland.
As we have already noted, and despite the recent reimbursement setback with SMC, these are still early days for the commercialisation of the company's adrenal franchise targeting disorders such as CAH and adrenal insufficiency (AI), where patients suffer from low levels of cortisol. For the CAH patient, in particular, there is a need for a treatment that mimics the normal physiological release and better addresses the balance between elevated androgens and elevated glucocorticoids while also reducing the risk of life-threatening adrenal crisis.
Currently, Efmody is approved for adolescent and adult CAH in Europe. However, studies are ongoing to take Efmody into AI in Europe with the CHAMPAIN trial (data available end 2022), and in CAH in the US, with the Phase 3 CONnECT study also underway. As data from these studies become available, we anticipate a greater appreciation of the benefit associated with Efmody's circadian delivery of hydrocortisone, particularly in CAH patients, who suffer from a build-up of androgens overnight.
We look forward to the full suite of Diurnal's AI (including CAH) products becoming available over the coming years.
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Diurnal Group is a client of Calvine Partners, and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information contained in this publication should be considered as any form of advice.