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MHRA has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with CAH in Great Britain.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with congenital adrenal hyperplasia (CAH) in Great Britain (England, Wales, and Scotland). MHRA’s announcement follows from the approval of Efmody in the European Economic Area (EEA), which includes Northern Ireland, on May 28, 2021.
Efmody is a preparation of hydrocortisone that has been designed specifically for patients with CAH. The marketing authorization application of Efmody to the MHRA included detailed analysis of data from a Phase III study that involved 122 subjects and an open-label safety extension study.
“We are pleased to have received approval for Efmody from the MHRA and look forward to making Efmody available to CAH patients in Great Britain as the first licensed treatment specifically designed to mimic the physiological circadian rhythm of cortisol,” said Martin Whitaker, CEO of Diurnal, in a July 2, 2021 press release. “Today’s approval is yet another important step forward for Diurnal as we continue to drive towards becoming the world’s leading specialty endocrinology business.”
“I am excited to see Efmody approved in Great Britain as a treatment for patients with CAH, a rare condition where patients and doctors need to face the challenge of deficient cortisol production and adrenal androgen excess,” added Wiebke Arlt, professor at the Institute of Metabolism and Systems Research, University of Birmingham, in the press release. “Efmody has been developed for these patients, and I believe this drug approval provides a new option for the treatment of CAH patients, where there is a significant unmet medical need.”