BRIEF—EMA committee expresses view on Calliditas' application for setanaxib in Alport syndrome

The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on Swedish biotech Calliditas’ application for orphan drug designation in the European Union for setanaxib in Alport syndrome.

This COMP opinion will now go to the European Commission, which is responsible for adopting the decision in relation to the application for orphan designation and adding it to the community register of orphan medicinal products for human use.

Calliditas is targeting initiation of a randomized, placebo-controlled Phase II study evaluating setanaxib in Alport syndrome with around 20 patients in the next three months.

The company is currently investigating setanaxib in a Phase II proof-of-concept study in squamous cell carcinoma of the head and neck, as well as in a Phase IIb study in primary biliary cholangitis.

Setanaxib is also being evaluated in an investigator-led study in idiopathic pulmonary fibrosis.