EU approves Novartis' Ilaris for CAPS; AstraZeneca withdraws Zactima marketing applications

Swiss drug major Novartis' new biological medicine Ilaris (canakinumab) has been approved in the European Union to treat adults and children as young as four years old with cryopyrin-associated periodic syndrome (CAPS), a rare life-long auto-inflammatory disease with debilitating symptoms and few treatment options.

The accelerated EU decision follows approvals in the USA and Switzerland, where Ilaris was granted priority review in view of the significant unmet medical need. Ilaris is the only medicine approved in the EU for CAPS patients as young as four years old, and for patients with the most debilitating form of CAPS, neonatal-onset multisystem inflammatory disease (NOMID). It is a fully human monoclonal antibody given by injection under the skin once every two months - the longest dosing interval of any available treatment.

Meantime, Anglo-Swedish drug major AstraZeneca says that it has withdrawn the regulatory submissions for the use of its Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US Food and Drug Administration and the European Medicines Agency (EMEA). The applications were submitted to regulatory agencies in June 2009.

No overall survival with Zactima

The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint may not be sufficient for approval.