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EMEA gives extension to Celebrex's European arthritis licence

Published on 04/05/07 at 01:54pm

Pfizer's Celebrex has received European approval for a new indication to treat arthritis pain and inflammation.

The company will look to the licence extension to help revive its blockbuster painkiller's sales, which fell dramatically after the 2004 withdrawal of Merck's rival Cox-II Vioxx on safety grounds.

Celebrex remains one of Pfizer's biggest products with worldwide sales of $2 billion in 2006, but revenues almost halved after Vioxx was pulled from the market in 2004 and only recovered by 18% last year.

In the UK, the picture is not so promising for the drug. Sales of Pfizer's drug to GPs in England fell from £64 million in 2004 to £21 million in 2005 and then to £15 million last year.

Celebrex's new approval is for symptomatic relief in the treatment of ankylosing spondylitis (AS), a chronic inflammatory rheumatic disease. It affects approximately 1 in 200 men and 1 in 500 women in Britain, usually starting in late adolescence.

Dr Marwan Bukhari, consultant rheumatologist at the Royal Lancaster Infirmary, said: "This is good news for AS patients who suffer prolonged periods of severe pain because of the high inflammatory component of the disease."

In trials, Celebrex showed a significant improvement over placebo in pain, global disease activity and function in AS and similar pain relief when compared to a commonly used NSAID - diclofenac (Novartis Volterol).

Celebrex was approved through the EMEA's mutual recognition procedure, giving it a licence to treat AS in 17 European countries. The drug was first approved in Europe in 1999 and its existing indications cover the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Pfizer's UK managing director John Young said: "We are delighted that the European regulators, including the MHRA, have recognised that Celebrex is an effective and generally well-tolerated treatment particularly suited to the needs of eligible AS patients according to EMEA guidance and Summary of Product Characteristics."

Celebrex is one of the extensively studied drugs in its Cox-II class with trial data from more than 34,000 patients, he added.

The drug was generally well tolerated in clinical trials, but there were a number of commonly observed side effects, including upper respiratory tract infection, insomnia, dizziness and abdominal pain.

Since 2005, it has had to carry additional cardiovascular contraindications and precautions, in common with all Cox-IIs following the EMEA's post-Vioxx safety review of the class.

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