Source: European Medicines Agency
Area: News
The European Medicines Agency (EMA) has announced the withdrawal of the application for a centralised marketing authorisation for voclosporin (Luveniq®), which 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.
The original application, submitted to the EMA in February 2010, received a negative opinion by the Committee for Medicinal Products for Human Use (CHMP) in June 2011. The company submitted a re-examination request in July 2011 and it was under review by the CHMP at the time of the withdrawal notification.
The company have informed the EMA that they were unable to demonstrate to the satisfaction of the CHMP an overwhelming effect showing that the benefits of voclosporin outweigh ...
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