Stronger warnings for COX-IIs recommended
pharmafile | November 28, 2003 | News story | |Â Â Â
A European Union safety review of the COX-II inhibitor class of drugs has recommended stronger labelling for painkiller treatments for patients with gastrointestinal and cardiovascular disease risk.
The recommendations from the European Union medicines committee the CPMP now go forward to the European Commission, who are expected to make their final ruling in the New Year.
The investigation into the class, which is dominated by Merck Sharp & Dohme's Vioxx and Pfizer's Celebrex, concluded that the benefit-risk balance for the products remained positive for the target patient populations, but that all products in the class needed reinforced warnings.
The COX-IIs class promised to equal the efficacy of existing NSAIDs without the gastrointestinal problems, but reports of adverse reactions have undermined these claims and uncovered other safety concerns.
Bextra, Pfizer's follow-up to Celebrex was approved in November 2001, but a small number of patients experienced hypersensitivity reactions (such as anaphylactic shock) and various severe skin reactions to the drug, which can all be fatal.
The CPMP has responded to these reports by recommending that warnings for these reactions should be included on all the medicines, a move which could level out competitors' claims if approved.
Pfizer's Celebrex, Bextra and Dynastat and MSD's Vioxx (the market leader in Europe) and Arcoxia have all been included within the recommendation, but Novartis' new entrant to the market, Prexige (lumiracoxib) has not.
The drug was not included because it had not been approved when the investigation began, but gained approval in the UK in September, with other EU countries set to recognise the approval in coming months.
But US regulator the FDA has expressed safety concerns about the drug, issuing it with a 'non-approvable' letter just days after its UK approval.
The rejection came as a surprise after Novartis presented clinical trials data from 13,000 patients, the biggest ever in the COX-II class.
The company said it would work hard to address the problems, but analysts Deutsche Bank downgraded its expectations for the drug, cutting in half its forecast sales in 2007 from just over $1 billion to $500 million, representing around 5% of the COX-II market.
