Novartis withdraws MA for Joicela; gets 'no' from UK's NICE for Afinitor

There were two pieces of negative news for Swiss drug major Novartis (NOVN: VX) yesterday, when the company received a negative ruling from the UK drug rationing watchdog for its kidney cancer drug, and the firm withdrew its application to resurrect European approval for a pain drug that had previously been pulled from the market in 2007.

The European Medicines Agency said it has been formally notified by Novartis of its decision to withdraw its application for a centralized marketing authorization for Joicela (lumiracoxib), a selective COX-2 inhibitor, 100mg film-coated tablets, which 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 DQA1*0102 allele.

The application for the MA for Joicela, originally known as Prexige, was submitted to the Agency on December 3, 2009. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP). In its official letter to the EMA, the company stated that its decision to withdraw the application was based on its inability to address the CHMP’s request to provide additional data within the timeframe allowed in the centralized procedure.