Diurnal shrugs off German assessment on Alkindi

Specialty UK-based pharma Diurnal (AIM: DNL) has dismissed the significance of a clinical benefit dossier assessment on the pediatric adrenal insufficiency treatment Alkindi (hydrocortisone granules in capsules) by the German Institute for Quality and Efficiency in Health Care (IQWiG).

The assessment states that Alkindi’s benefit over generic hydrocortisone has been not proven, as the appropriate comparator therapy was not implemented in any of the studies.

Diurnal did not include a hydrocortisone comparator arm in its pivotal studies with Alkindi due to the lack of a specific pediatric dose appropriate licensed form of hydrocortisone. The assessment does not affect the company’s commercial expectations for its product in Europe.