DNL.L Share News (DNL)

(Sharecast News) - Speciality pharmaceutical company Diurnal Group announced on Friday that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for 'Efmody', or hydrocortisone modified-release hard capsules, as treatment for adult and adolescent patients with the rare congenital adrenal hyperplasia (CAH) condition.
The AIM-traded firm said the marketing authorisation for Efmody from the MHRA would apply in England, Wales and Scotland, and followed the recent approval of the product in the European Economic Area, including Northern Ireland, by the European Commission in May.

It said the submission to the MHRA included detailed analysis of data from its phase 3 study, which was the largest-ever completed interventional clinical trial in CAH involving 122 subjects, as well as an open-label safety extension study of Efmody.

To facilitate timely commercial availability, Diurnal said it had already started market access activities in Great Britain, with the commercial launch expected in the first quarter of 2022.

The firm said it was intending to mirror its strategy for 'Alkindi', or hydrocortisone granules in capsules for opening, by commercialising the product itself in Great Britain, as well as other core European markets.

Following feedback from the MHRA and consistent with the approach taken in the European Economic Area, the company said it had decided not to pursue orphan drug status for Efmody in Britain, as it would likely cause a significant delay to the commercial launch.

The board said that while orphan designation would provide market exclusivity for 10 years from launch, the company currently held patents for Efmody for the treatment of patients with CAH, and believed those patents would provide sufficient protection for Efmody until at least 2033 in Britain.

"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 chief executive officer Martin Whitaker.

"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."

At 1314 BST, shares in Diurnal Group were up 0.93% at 64.9p.