(Sharecast News) - Specialty pharmaceutical company Diurnal Group has submitted a 'New Drug Application' (NDA) to the US Food and Drug Administration (FDA), for the regulatory approval of 'Alkindi Sprinkle', or hydrocortisone granules in capsules for opening, as a replacement therapy of adrenal insufficiency in infants, children and adolescents in the US, it announced on Monday.
The AIM-traded firm said the submission followed a positive meeting in the first quarter of 2019 with the FDA, which confirmed its clinical and regulatory pathway for Alkindi in the US.
It said the pathway was based on a development programme for Alkindi, including a study to demonstrate bioequivalence with the US reference product, as well as a safety evaluation and tolerability extension study in Europe, which would provide valuable long-term exposure data in support of market access in the country.
The studies were completed in 2018, and regulatory approval of Alkindi in the US was expected in late 2020.
Diurnal said it would also request the confirmation of 'Orphan Drug Status' for Alkindi in paediatric adrenal insufficiency, which would require it to demonstrate significant clinical benefit for the product compared to existing therapies.
In addition, the company said it was continuing to progress discussions with potential partners for Alkindi in the US, in a bid to optimise market access for patients.
"The submission of a New Drug Application for Alkindi in the US builds on the successful launch of the product in Europe and further validates our vision of becoming a world-leading endocrinology specialty pharmaceutical company," said chief executive officer Martin Whitaker.
"If approved, Alkindi will provide a major breakthrough in the US as the only licensed treatment specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need.
"We look forward to working closely with the FDA to bring this important product to patients."
At 1136 GMT, shares in Diurnal Group were down 1.25% at 31.6p.
11 Jul 2016 06:45