AstraZeneca today announced that AXANUM, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole, has received positive agreement for approval in 23 European Union member countries and in Norway. AXANUM is indicated for prevention of cardiovascular (CV) events such as heart attack or stroke, in high-risk CV patients in need of daily low-dose ASA treatment and who are at risk of gastric ulcers.
Low-dose ASA (commonly known as aspirin) is recommended mainstay therapy for patients with high-risk for cardiovascular events. About one third of these patients are also at increased risk of stomach ulcer. Low-dose ASA further increases the risk for gastric ulcers and gastrointestinal bleeding. In fact, the most common reason for stopping low-dose ASA treatment is upper gastrointestinal problems. The consequences of interrupting low-dose ASA treatment can be severe, increasing the risk of a heart attack or stroke as early as eight to 10 days later.
AXANUM is the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers. That means AXANUM has the potential to provide continuous CV protection in this patient population.
The EU decision took place under the decentralised procedure (DCP), with Germany acting as reference member state. This process is now followed by national approvals and local pricing and reimbursement discussions.
Tony Zook, Executive Vice President of AstraZeneca's Global Commercial Organisation said: "AstraZeneca has had some significant regulatory approvals this year, and we're pleased with this positive agreement for AXANUM in Europe. We will now work with relevant health authorities to secure reimbursement decisions and get onto formularies to bring this medicine to patients as soon as possible."
AXANUM once-daily pill is a combination of low-dose ASA 81mg and esomeprazole 20mg. Esomeprazole, which is the active ingredient in the proton pump inhibitor (PPI) Nexium, is approved for the risk reduction of peptic ulcer development in low-dose ASA patients and is the only PPI approved for the risk reduction of re-bleeding in peptic ulcer bleed patients.
AstraZeneca submitted a Marketing Authorisation Application in the EU via the Decentralised Procedure for AXANUM on 30 April 2009. The EU Concerned Member States include: Austria; Belgium, Denmark, Luxemburg, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Finland, France, Italy, Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia and Norway. The Member States will now work to pursue pricing/reimbursement and national approvals.
About the OBERON Study
The data from the OBERON trial, a double-blind, randomised, prospective analysis of 2426 patients, revealed that esomeprazole 20mg reduced the cumulative proportion of patients with peptic ulcers after 26 weeks of treatment by 85%.
About the ASTERIX Study
Data from the ASTERIX study, a double-blind, randomized, placebo-controlled of 992 patients, reported that Nexium 20 mg once daily was significantly more effective than placebo in preventing gastric and/or duodenal ulcers and associated upper GI problems in this patient group.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.