Prexige wins approval in UK
pharmafile | December 15, 2005 | News story | Sales and Marketing |Â Â Â
Prexige has finally been launched in the UK after a safety review of the entire Cox-II class delayed its entrance to the market.
Marketed by Novartis, Prexige has endured a two-year fight to reach the UK market after the withdrawal of Vioxx prompted the EMEA to review the safety of other drugs in the class.
Novartis agreed to delay the launch of its Cox-II inhibitor until the completion of the EMEA review, which imposed new contraindications and warnings on all Cox-IIs.
The new warnings and the fallout from the Vioxx withdrawal could have a substantial affect on the take-up of Prexige (lumiracoxib), which Novartis says will initially be targeted as a secondary care drug.
Dr Tim Cave, UK medical director of Novartis, said: "Talking to secondary care experts, we felt it was best for Prexige to be used by experts in hospitals.
"The treatment options for patients with osteoarthritis are limited in what they can use and many are being treated with paracetomal and NSAIDs. We believe Prexige gives them a new alternative."
Novartis claims that Prexige has a similar cardiovascular safety profile to other Cox-II inhibitors, but has a superior gastrointestinal safety profile compared to older NSAIDs.
Its UK approval for the treatment of acute pain and osteoarthritis will pave the way for its launch across Europe under the mutual recognition procedure.
The Cox-II market in Europe has a dramatically different look to it following the withdrawal of Vioxx and the suspension of Pfizer's Bextra.
Prexige will, however, be up against two competing Cox-IIs, Pfizer's Celebrex and Merck's Arcoxia.
Celebrex has witnessed a sales slump from around $3.5 billion to $1.7 billion in the first nine months of this year, following the withdrawal of Vioxx.
But Dr Cave said the 18,000 osteoarthritis patient-TARGET (Therapeutic Arthritis Research and Gastrointestinal Event Trial) which compared Prexige with two established NSAIDs, narproxen and ibuprofen, provides clinicians with the reassurance of the risks and benefits of Prexige.
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