Source: European Medicines Agency (EMA)
Area: News
The European Medicines Agency (EMA) has announced that it has been formally notified by Lux Biosciences GmbH of its decision to withdraw its application for a centralised marketing authorisation for the medicine voclosporin 10 mg soft capsules (Luveniq).
Voclosporin 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 14 September 2007.
The company stated that they were unable to demonstrate to the satisfaction of the Committee for Medicinal Products for Human Use (CHMP), an effect showing that the benefits of voclosporin outweigh its risks, and thus would qualify for a recommendation for authorisation with one pivotal study only.
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