Specialty pharmaceutical company, Diurnal, has announced, in an April 1, 2020 press release, that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).
Chronocort is a modified release preparation of hydrocortisone that has been designed to treat a rare condition, congenital adrenal hyperplasia (CAH). The MAA for Chronocort was originally submitted in December 2019.
“We are pleased to announce that our MAA for Chronocort has been validated and we look forward to working with the EMA during the review process,” said Martin Whitaker, CEO of Diurnal, in the press release. “This is another important step towards the targeted recommendation for approval of our second product in Q1 2021. There is a significant need for new therapies to improve outcomes for adult and adolescent patients with CAH, which still results in increased morbidity and mortality. Following the recent [United States] licensing agreement with Eton Pharmaceuticals for Alkindi Sprinkle and £11.2 million (US$13.8 million) placing, Diurnal now has a strong cash position to progress through to and past the anticipated approval date for Chronocort.”