Novartis pulls application for an extended indication for Zometa in Europe

Swiss drug major Novartis (NOVN: VX) has formally advised the European Medicines Agency (EMA) of its decision to withdraw its application for an extension of indication for the centrally authorized drug Zometa (zoledronic acid) 4mg powder and solvent for solution for infusion and 4 mg/ 5 ml concentrate for solution for infusion.

On December 22, 2009, Novartis submitted an application to extend the marketing authorization for Zometa to include the adjuvant treatment of hormone receptor-positive early breast cancer (EBC) in premenopausal women for whom hormonal therapy is recommended. At the time of withdrawal, the application was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).

Zometa was first approved in the European Union on March 20, 2001. It is currently authorized for the prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcemia) in patients with advanced malignancies involving bone, as well as for the treatment of tumor-induced hypercalcemia.