Novartis Withdraws Marketing Authorization Application for Joicela

The company stated its decision was based on its inability to address the CHMP’s request to provide additional data within the timeframe allowed in the centralised procedure.

The European Medicines Agency (EMA) has been formally notified by Novartis of its decision to withdraw its application for a centralised marketing authorisation for the medicine Joicela (lumiracoxib), 100 mg film-coated tablets.

Joicela was intended to be used for symptomatic relief in the treatment of osteoarthritis of the knee and hip in patients who are non-carriers of the DQA10102 allele.

The application for the marketing authorisation for Joicela was submitted to the Agency on 3 December 2009. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

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