Diurnal gets first drug approval by US FDA

The US Food and Drug Administration has approved Alkindi Sprinkle (hydrocortisone oral granules) as replacement therapy in pediatric patients with adrenocortical insufficiency (AI) from UK specialty pharma company Diurnal (AIM: DNL), making it only the third listed AIM company to obtain FDA approval for a product, according to Hardman research, and sending Diurnal’s shares up 10.5% to 72.90 pence by late morning.

This approval is based on a positive review of data from the company’s comprehensive development programme for Alkindi Sprinkle, including a study to demonstrate bioequivalence with the US reference product, as well as a safety evaluation and tolerability extension study in Europe, which provides valuable long-term exposure data in support of market access in the USA.

Diurnal has partnered with Eton Pharmaceuticals (Nasdaq: ETON) for the commercialization activities of Alkindi Sprinkle in the USA, including pricing and reimbursement. Eton will initially use product from Diurnal’s European Alkindi supply chain, with an option to establish its own supply chain in the USA in the future. Eton has stated that the US commercial opportunity for Alkindi Sprinkle could be greater than $100 million.