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EMA's CHMP has issued a positive opinion for Diurnal's second product in Europe, Chronocort (Efmody), to treat CAH.
Diurnal Group has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for its second product in Europe, Chronocort (Efmody).
Efmody—hydrocortisone modified-release hard capsules—has been granted the recommendation as a treatment of adult and adolescent patients (12 years and older) with congenital adrenal hyperplasia (CAH). CAH is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase.
“We are delighted that the CHMP endorses Efmody as a treatment option for adult and adolescent patients suffering from CAH,” said Martin Whitaker, CEO of Diurnal, in a March 26, 2021 press release. “We look forward to expanding our commercial portfolio with the planned launch of Efmody across Europe alongside our first product Alkindi, to provide life-long treatment for patients with CAH, enabling Diurnal to continue to drive towards becoming a world-leading specialty endocrinology business.”
A formal approval of marketing authorization by the European Commission is expected to be received in June 2021.