Prexige

(lumiracoxib)

Prexige (lumiracoxib)

Prexige Approved In United Kingdom

Prexige (lumiracoxib) has been approved (September 16, 2003) by the Medicines and Healthcare products Regulatory Agency (MHRA in the United Kingdom. Novartis announced that Prexige was approved in the U.K. for: symptomatic relief of osteoarthritis (100-200mg daily), short-term relief of moderate to severe acute pain associated with primary dysmenorrhea, dental surgery and orthopedic surgery (400mg daily).

First European Approval

The U.K.'s MHRA approval is the first European approval for Prexige and will act as the reference member state in the mutual recognition procedure in Europe. The decision was based on applications for regulatory approval which included more than 13,000 adult patients across the world and a total of 50 clinical and clinical pharmacology trials, making it the largest regulatory filing in its therapeutic class. Five Latin American countries also have given a thumbs up to Prexige.

COX-2 Inhibitor

Prexige is in the class of drugs known as COX-2 inhibitors.
This drug class includes the drug Celebrex and two drugs which have since been withdrawn from the market, Vioxx and Bextra. COX-2 inhibitors are nonsteroidal anti-inflammatory drugs. Because drugs in this class selectively inhibit COX-2, side effects in the stomach and intestine are reduced.

Novartis' Prexige may be developing an edge over the other COX-2 inhibitors. After a report appeared in the August 2001 issue of the Journal of The American Medical Association regarding the cardiovascular concerns of Eric Topol, M.D. and colleagues at the Cleveland Clinic, growth of Celebrex and Vioxx slowed somewhat. Drug companies argued that the concerns that COX-2 inhibitors might cause heart problems were a result of "a misguided analysis of existing data". However, the concerns never fully lifted.

Novartis' response to the concerns was to run extra clinical trials to try and prove that Prexige does no cardiovascular damage. In addition to the original 13,000 patient study, Novartis is conducting an 18,000 patient study worldwide known as TARGET (Therapeutic Arthritis Research & Gastrointestinal Event Trial). TARGET is the world's largest arthritis clinical trial to date. TARGET will:

- Evaluate the safety, tolerability, and efficacy of Prexige compared to the NSAIDs ibuprofen and naproxen over 12 months.

- Examine as a primary objective, the gastrointestinal safety of Prexige compared with the NSAIDs.

- Examine as a pre-specified secondary endpoint, cardiovascular safety.

Some analysts believe the U.S. FDA may wait for the extensive data from the TARGET trial which is due in mid-2004 before deciding whether to approve Prexige.

Prexige/Lumiracoxib Updates

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Sources: arthritis.about.com - Novartis Media Release: Prexige, a novel COX-2 selective inhibitor approved in the United Kingdom, 9/16/2003; Novartis pain drug Prexige wins British OK, Reuters, 9/16/2003; Novartis Looks To Prexige, A New Arthritis Drug, Forbes, 4/19/2002; Novartis Launches TARGET, Largest Worldwide Arthritis Clinical Trial, Press Release, 5/20/2002