EU Clears Arthritis Drug

A COX-2 from Novartis is approved.
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Novartis

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has received European Union approval to sell an arthritis drug that belongs to the same class as

Merck's

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Vioxx and

Pfizer's

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Celebrex.

The Novartis drug, Prexige, has already been cleared in more than two dozen countries, including the U.K. and Canada. The decision by EU regulators means the drug will be available in all 26 member nations in 2007 or 2008, Novartis says.

In the EU, Prexige can be sold to treat osteoarthritis, or the degeneration of the joints, in the knee and hip.

Novartis asked the Food and Drug Administration to vote in support of Prexige in 2002, but the agency wanted more clinical data. The Swiss drugmaker later withdrew the request to conduct more tests. Novartis now says it will refile its application next year to get the drug cleared in the U.S., a market where regulators have been particularly tough on products like Prexige.

Prexige offers "similar pain relief" to Celebrex, Novartis claims. The company says clinical trials show its drug causes fewer gastrointestinal problems than traditional pain relievers such as ibuprofen and naproxen, which are available in prescription strength, as well as over-the-counter. Medications of this type are called nonsteroidal anti-inflammatory drugs, or NSAIDs.

Drugs like Prexige belong to a group known as COX-2 inhibitors. Developers of the COX-2 drugs have tried to show that they cause fewer stomach-related side effects than NSAIDs, but in the U.S., the FDA only allowed Vioxx to use that claim in its marketing efforts.

Novartis also says Prexige has demonstrated a "similar cardiovascular safety profile and a significantly smaller effect on blood pressure" than NSAIDs.

Celebrex is the only COX-2 inhibitor drug available in the U.S., and it's also sold in foreign markets. Merck pulled Vioxx in September 2004, citing a clinical trial that said patients taking Vioxx for more than 18 months had a higher risk of cardiovascular problems than those receiving a placebo. In April 2005,

Pfizer stopped selling the COX-2 drug Bextra after the FDA said the drug's risks outweighed its benefits.

Arcoxia, a Merck COX-2 drug, is available in 62 foreign markets. The FDA granted

conditional approval in October 2004, but the agency won't deliver a final verdict until it sees more data on the product's safety and effectiveness. Dynastat, another Pfizer COX-2, is sold in some international markets, but the

FDA rejected it in September 2005.

Recently, sales of Celebrex sales have started a slow-motion comeback even though the drug carries a "black box" warning -- the strictest FDA alert -- about cardiovascular and gastrointestinal risks. NSAIDs have the same warnings.

Third-quarter Celebrex sales rose 20% from last year to $537 million, and Pfizer has predicted full-year sales of $2 billion. That's better than last year's $1.73 billion but still well below the peak sales of $3.3 billion in 2004.

Later this month, Pfizer will ask an advisory panel to the FDA to approve Celebrex as a treatment for juvenile rheumatoid arthritis in patients at least 2 years old. Celebrex can now be sold for six different indications, including osteoarthritis and rheumatoid arthritis, managing acute pain in adults and reducing certain colon polyps.