Novartis files COX-II contender amid class safety concerns
pharmafile | October 22, 2003 | News story | |
Novartis has submitted its COX-II inhibitor Prexige to US and European regulators with data from 13,000 clinical trial patients 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 safety profile will merit superiority claims over existing NSAIDs and other COX-IIs.
Pharmacia and Pfizer's co-promoted Celebrex led the arthritis pain market with $3.1 million sales last year, closely followed by Merck's Vioxx, but the products, and their respective follow-up drugs Bextra and Arcoxia, have had their safety profile repeatedly questioned this year.
The COX-IIs were promised to equal the efficacy of existing NSAIDs without the gastrointestinal problems, but post-marketing studies have undermined these claims and uncovered other safety concerns.
Novartis now expects to launch Prexige (lumiracoxib) by 2004 and some analysts predict it can overtake market leaders Celebrex and Vioxx within a few years.
Christian Downton, Research Analyst at Frost & Sullivan, said: "Prexige is going to present itself as quite a strong rival to Vioxx and Celebrex because Novartis has demonstrated it has a good safety profile, which is very important in this market".
In June, Celebrex was granted approval by the FDA to claim a better safety profile than rival Vioxx, after conducting a clinical trial involving 4,000 patients.
The Celebrex claim was reinforced by research published in the BMJ that linked high-doses of Vioxx to an increased risk of coronary heart disease.
Concerns about cardiovascular complications have persuaded the EMEA to launch an inquiry into the whole class and is expected to publish its findings in early 2003. This includes Bextra, currently undergoing marketing approval and now the subject of new label warnings after post-marketing surveillance showed rare but potentially fatal hypersensitivity reactions (such as anaphylactic shock) and various severe skin reactions in some patients.
Meanwhile, Merck's Arcoxia, already approved in the EU, has had its submission to the FDA delayed until the second half of 2003 following requests for further cardiovascular safety data and its use in the treatment of acute pain.
"The safety concerns will somewhat limit the revenues that all the competitors can gain from these products, but they are still good products that meet the need of the market", said Christian Downton.
A new arthritis non-COX-II drug currently in development by German company Merckle may offer a better gastrointestinal safety profile than the coxibs, according to new trial data.
The studies of licofelone at twice the anticipated therapeutic dose indicated an incidence of gastroduodenal ulcers in only 5.6% of patients also taking low-dose aspirin, compared with 2.4% in patients on licofelone only. This compared with 25.6% and 23% for patients taking naproxen with and without aspirin, respectively.
"These new findings strengthen licofelone profile as potentially providing a safe and effective treatment in all osteoarthritis patients including those who are at risk of cardiovascular disease and are therefore co-administering aspirin", said Prof Stefan Laufer, University of Tuebingen, Germany, who has been involved in the studies.
