Lux Biosciences withdraws European marketing application for uveitis drug Luveniq

The European Medicines Agency has been formally notified by the European subsidiary of USA-based biotech firm Lux Biosciences of its decision to withdraw its application for a centralized marketing authorization for the medicine Luveniq (voclosporin), 10 mg soft capsules.

Luveniq was intended to be used for the treatment of patients with chronic non-infectious uveitis involving the posterior or intermediate segments of the eyes as characterised by a high degree of inflammation and in whom corticosteroids are inappropriate, do not provide adequate control or cannot be tapered below 10mg/day. Voclosporin was designated an orphan medicinal product on in September 2007.

The marketing application for Luveniq was initially submitted to the Agency on February 10, 2010 and the drug received a negative opinion by the Committee for Medicinal Products for Human Use (CHMP) on June 23, 2011. The company submitted a re-examination request for Luveniq on July 8 this year. At the time of the withdrawal it was under review by the CHMP.