Canada OKs limited use of Novartis arthritis drug

Canada has approved the limited use of Novartis’s arthritis drug Prexige, the first new medication to be allowed in a class of drugs that had come under question because of possible heart problems.

The Swiss drugmaker announced the Canadian approval on Tuesday for treating arthritis in the knee, hours after it said the European Union approved the same drug for knees and hips.

It said it showed no significant difference in cardiovascular risks but was safer on the stomach and intestines than ibuprofen or naproxen.

Prexige is one of several COX-2 inhibitors, drugs that were originally designed to be safer long-term treatments than ibuprofen, naproxen or aspirin—known as traditional non-steoroidal anti-inflammatory drugs or NSAIDs.

But after research emerged showing COX-2 inhibitors may increase the risk of heart attacks, Merck & Co. Inc. pulled its drug Vioxx from worldwide markets in 2004 and Canada banned Pfizer Inc.‘s Bextra.

Celebrex, also made by Pfizer, is the only COX-2 product currently sold in Canada.

Prexige’s approval was based on extensive trials and follows recommendations issued by a Canadian panel of health experts earlier this year.

“The large body of evidence supporting Prexige demonstrate its clear GI (gastrointestinal) advantage with no significant difference in cardiovascular risk when compared to traditional NSAID treatments,” Novartis quoted Dr. William Bensen, a consultant at McMaster University, as saying.

A Health Canada advisory panel recommended in June that the drugs be properly labeled to warn of the possible risks of heart attack or stroke and said the banned drugs would only be considered if resubmitted for approval under the new guidelines.

Novartis said it was filing additional data with Health Canada for Prexige to be allowed to be used for more than just knees. It is also asking the United States for approval.