AZ submits Nexium-aspirin combination for EU approval
pharmafile | June 7, 2010 | News story | Sales and Marketing | AstraZeneca, Nexium, aspirin
AstraZeneca is seeking European approval for a new version of its anti-ulcer blockbuster Nexium that combines the pill with aspirin.
The new combination, proposed brand name Axanum, includes a low-dose of aspirin (acetylsalicylic acid or ASA) and Nexium’s active ingredient esomeprazole.
The company has filed Axanum with European reguatlors for approval in a fixed-dose combination of 81mg ASA/20mg esomeprazole.
It is aimed at preventing cardio- and cerebrovascular (CV) events, such as myocardial infarction or stroke, in patients who have continuous ASA treatment and are at risk of developing ulcers.
Aspirin is often used for people at high risk of CV events, up to 30% of whom then stop this low-dose therapy when ulcers and ulcer-related complications form.
But AstraZeneca says even a break from treatment can put people at risk of a potentially life-threatening heart attack as early as a week after stopping.
It points to two phase III studies for those receiving low-dose ASA therapy, ASTERIX and OBERON, which took in more than 3,400 patients and demonstrated the clinical benefit of low-dose ASA plus esomeprazole.
ASTERIX found esomeprazole 20mg once daily was significantly more effective versus placebo in preventing gastric and/or duodenal ulcers and associated upper GI symptoms.
Meanwhile OBERON showed daily acid-suppressive therapy with esomeprazole 20mg or 40mg effectively prevents these ulcers as well as upper GI symptoms in patients at increased risk of ulcer development.
AstraZeneca has submitted a marketing authorisation application under the decentralised procedure which applies to medicines which have not yet received any authorisation.
In April the manufacturer paid $647 million to buy Merck’s interest in AstraZeneca’s own non-PPI products such as Atacand, Lexxel and Entocort. The company then has an option to acquire Merck’s interest in the PPI products, including Nexium, from 2012.
Adam Hill
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