Novartis Pharmaceuticals AG (BASEL, Switzerland) announced that health regulators in the UK and Germany have suspended the marketing and sale of Prexige® (lumiracoxib), a COX-2 inhibitor for patients with osteoarthritic pain, following a review of the drug's benefit/risk profile. Novartis will also comply with a request from the Austrian health authority to suspend sales pending a final decision by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in the EU. Novartis is informing regulatory agencies around the world of these changes, which come after similar actions in other countries in recent months.

The suspensions were announced after CHMP initiated a so-called "Article 107" procedure on November 16. This occurs when an EU member state withdraws, suspends, or changes the status of a nationally authorized medicine after a review of safety data. This enables CHMP to prepare an opinion on whether the regulatory action should apply throughout the EU. Other EU countries may decide to independently suspend the marketing authorization or sale of Prexige ahead of a decision by CHMP, which is expected in December.

The actions in Europe come after an Urgent Safety Restriction was initiated in August 2007 for the Prexige 100-mg dose. Novartis worked with European regulators to update prescribing information, including additional warnings and precautions about liver monitoring for patients. Prexige was first withdrawn in August 2007 in Australia where a number of liver side effects were reported, including two deaths, associated with Prexige >100 mg. No deaths have been reported worldwide with the 100-mg dose.

According to Novartis, the latest analysis of patients taking the Prexige 100-mg dose showed nine severe hepatic events reported worldwide. This corresponds to a rate of 5.19 events per 100,000 patient-years, which is within the rate expected for NSAIDs. Although a direct comparison cannot be made between spontaneous reports and epidemiological data, a major analysis of epidemiological studies on NSAID-induced liver injury resulting in hospitalization showed an incidence rate of between 3.1 and 23.4 per 100,000 patient-years.

Prexige is available in some European countries as a 100-mg, once-daily treatment for osteoarthritic pain following EU approval through the Mutual Recognition Procedure in October 2006, with the UK as the reference member state. Prexige is also marketed and sold in Belgium, Cyprus, Hungary, Malta, Portugal, and Sweden. In the first 9 months of 2007, Prexige had net sales of $8 million in Europe.
 
Novartis will continue discussions with European health regulators, and with the US FDA following its decision in September 2007 not to approve Prexige, to determine how to make this treatment option available to appropriate patients.