FDA rejects Novartis' painkiller Prexige

The US Food and Drug Administration says that Swiss drug major Novartis' COX-2 inhibitor Prexige (lumiracoxib) is not approvable, based on the drug's side effect profile. The drug, which has been cleared as a once-daily treatment for the pain associated with osteoarthritis in more than 50 countries worldwide, has been linked to liver enzyme elevation.

The decision is a further blow for Novartis' Prexige program following the decision by the Australian Therapeutic Goods Administration to revoke approval for the drug based on concerns about its liver safety profile, particularly in terms of the 200mg and 400mg dosage formulations (Marketletter August 20). In addition, Health Canada, which first granted the 100mg version of the product marketing approval in 2006, said last month that it is to conduct a review of safety data (Marketletter September 3).

In response, Novartis said that additional data it had submitted to the FDA had demonstrated that the 100mg Prexige formulation resulted in liver enzyme elevations, to three times the upper limit, in only 0.85% of those treated, and that this was comparable to currently-available non-steroidal anti-inflammatory drugs. The firm also cited the TARGET trial as evidence of the product's improved gastrointestinal side effect profile with respect to other NSAIDs in patients not taking aspirin.