Date: 2026-04-07 (Immedica press release; European Commission decision 13 Mar 2026)
Source: Immedica Pharma AB — https://www.immedica.com/en/press/efmodyr-modified-release-hydrocortisone-granted-extension-indication-adrenal-insufficiency
What happened?
Immedica announced that the European Commission has granted an extension of indication for Efmody® (modified-release hydrocortisone) to include treatment of adrenal insufficiency (AI) in adolescents aged 12 years and over and adults in the European Union. Efmody was already authorised in the EU for congenital adrenal hyperplasia (CAH); this decision adds AI to the labelled indications.
What is the medicine?
Efmody is a modified-release hydrocortisone hard capsule. The company describes a twice-daily “toothbrush” regimen intended to better approximate the natural cortisol rhythm. This is a news summary, not prescribing or dosing advice.
Study snapshot
The approval is based on final results from study DIUR-016-AI: a double-blind, double-dummy, two-way cross-over, randomised phase II study of efficacy, safety and tolerability of modified-release hydrocortisone (Chronocort/Efmody) versus another hydrocortisone preparation (Plenadren) in AI.
Who is it for?
According to the labelled indication, adolescents aged 12+ and adults with adrenal insufficiency and with CAH. Whether and when it is appropriate for an individual patient depends on clinical guidance and the treating clinician. Other country announcements have also noted it is not positioned as first-line therapy on diagnosis.
Access / cost
This is an EU indication extension. National reimbursement, prescribing rules and supply are decided country by country. Turkish licensing, import or reimbursement is not covered in this release.
What it may mean for patients in Türkiye
An EU-wide AI indication is a global development for the adrenal insufficiency community and may influence later regional access discussions. Treatment choices in Türkiye remain with the patient’s endocrinologist; this article is for information only.
Warning: This is a news summary; it is not dose or treatment advice. Ask your endocrinologist.