Santhera Pharmaceuticals Holding AG said the European Medicines Agency recommended granting the company's rare lung disease therapy POL6014 orphan designation in the EU.
POL6014 is an investigational treatment of cystic fibrosis, a rare and inherited disease characterized by the buildup of sticky mucus in the lungs and digestive system. The condition — which affects about 35,000 people in the EU — could lead to persistent lung infections, trouble breathing and digestion problems.
Santhera will evaluate the drug in a phase 1/2 study.
The company expects to receive orphan drug designation within 30 days following the positive opinion by the EMA's Committee for Orphan Medicinal Products.
Switzerland-based Santhera, which develops therapies for rare diseases affecting the eyes, muscles and lungs, acquired global rights to commercialize POL6014 from Polyphor AG in February.