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Delayed Celebrex successor approved in Europe

Published on 29/10/03 at 09:57am

Pfizer's follow up to its multi-billion dollar painkiller Celebrex has been approved for marketing across the European Union following a lengthy delay.

The company's second-generation COX-II inhibitor Bextra has been licensed for the treatment of pain and inflammation associated with rheumatoid arthritis, osteoarthritis and severe menstrual pain.

Bextra received a positive opinion from the CPMP on 25 July 2002 but has been delayed since then following reports of side-effects from the US, where it had already been launched.

The reports of serious hypersensitivity reactions, such as anaphylaxis, and serious skin reactions also applied to Pfizer's related product, the injectable COX-II Dynastat, forcing the company to change the product's prescribing information.

Celebrex and Merck's Vioxx have been two of the biggest marketing successes of recent years, becoming the fasting growing medicines of all time. European countries have, however, not taken to the drugs to the same extent as the US, largely due to scepticism about their cost-effectiveness. Vioxx is the biggest COX-II in Europe, in contrast to the US, where Celebrex leads the market.

Growing doubts about the central claim of the class to have fewer of the gastrointestinal side-effects of traditional NSAIDs and cardiovascular safety issues have undermined their popularity, despite intense efforts from manufacturers to produce ever more conclusive data.

Despite these setbacks, analysts say Bextra could reach sales of up to $1.7 billion in 2002, slightly short of Celebrex's $2 billion and Vioxx's $3 billion.

Pfizer's new product will primarily be marketed in Europe as Bextra, but will be named Valdyn and Kudeq in some European countries.

The European Commission's approval is valid in all 15 EU member states and also extends to Norway and Iceland. Pfizer expects to begin European launches this year.

Novartis has submitted its COX-II inhibitor Prexige to US and European regulators with data from an exceptionally high number of clinical trial patients 13,000 to prove its safety and efficacy profile.

The trial is the largest ever to be conducted for an arthritis treatment and Novartis hopes the data will convince the FDA and EMEA that the drug's safety profile will merit superiority claims over existing NSAIDs and other COX-IIs.

Meanwhile, Merck's Arcoxia, already approved in the EU, had its FDA submission delayed until the second half of 2003 late last year following requests for further cardiovascular safety data and its use in the treatment of acute pain.

1.8 million prescriptions were written for Vioxx in England in 2002 (127,000 in 2001) against 1.4 million for Pfizer's Celebrex (674,000 in 2001). MSD's follow-up to Vioxx, launched in April 2002 as Arcoxia, accounted for 87,000 prescriptions.

Boehringer Ingelheim's Mobic and Shire's Lodine SR, which have a similar action earned, 1 million and 191,000 prescriptions respectively.

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