MHRA approves Efmody (modified-release hydrocortisone) for adrenal insufficiency in adolescents and adults in the UK – Immedica Pharma

Immedica Pharma AB is pleased to announce that the UK MHRA has approved Efmody (modified-release hydrocortisone) for the treatment of adrenal insufficiency in adolescents aged 12 years and over and adults in the United Kingdom.

Adrenal insufficiency is a rare and serious condition in which the body does not produce sufficient amounts of cortisol. Patients require lifelong treatment and careful management to mimic the body’s natural cortisol rhythm.

“The MHRA approval of Efmody is an important step forward for patients living with adrenal insufficiency in the UK. By expanding access to this innovative treatment, we hope to support patients in achieving a better quality of life, with less fatigue.” – Mark Bell, General Manager in the UK & Ireland.

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 hydrocortisones: Chronocort (Efmody) versus Plenadren (hydrocortisone) in AI.