Novartis’ Prexige cleared for approval across EU

Prexige (lumiracoxib), the Novartis treatment for osteoarthritis, has completed the mutual recognition process (MRP) that means the drug has been “cleared for approval” across the EU.

The drug was first launched in the UK in December 2005 and has received approval in 25 other countries. The completion of the MRP is based on clinical evidence showing that Prexige can provide effective pain release with a smaller incidence of gastrointestinal problems compared to widely-used non-steroidal anti-inflammatory drugs.

Novartis adds that Prexige is not like other selective COX-2 inhibitors – like Merck Sharp & Dohme’s (MSD) failed Vioxx drug – because it targets the site of pain and clears the bloodstream rapidly, into the affected joints.

Dr Gerd Burmester, professor of medicine at Humboldt University in Berlin, remarked: “[Not] all osteoarthritis patients respond to currently available pain medications.”

“Lumiracoxib has been extensively studied for both efficacy and safety and has the potential to provide a valuable new treatment option for physicians,” he added.

Novartis’ head of development for its pharmaceuticals business, James Shannon, stated that the company had worked closely with health authorities to allay worries over the safety of the drug, given the considerable problems with previously marketed COX-2 inhibitors like Vioxx.

Vioxx was withdrawn by MSD amid concerns over the increased risk of heart attacks and strokes after using the drug.