AstraZeneca says that Axanum, a fixed-dose combination of low-dose aspirin and its antiulcerant blockbuster Nexium (esomeprazole), has received positive agreement for approval in 23 European Union member countries and in Norway.
The combo is indicated for prevention of cardiovascular events such as heart attack or stroke, in high-risk patients in need of daily low-dose ASA (acetylsalicylic acid) treatment and who are at risk of gastric ulcers. The latter, ie aspirin, is recommended mainstay therapy for patients with high-risk for CV events but on its own further increases the risk for ulcers and gastrointestinal bleeding.
The Anglo-Swedish drugmaker notes that Axanum is" the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers", thus providing continuous CV protection in this patient population. Tony Zook, head of AstraZeneca’s global commercial organisation said: “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.”
The EU decision took place under the decentralised procedure with Germany acting as reference member state.
Vandetanib to be called Caprelsa in USA
Meantime, AstraZeneca has announced that the US Food and Drug Administration has approved the trade name Caprelsa for the recently approved orphan drug vandetanib, a treatment for medullary thyroid cancer that cannot be removed by surgery or that has spread to other parts of the body.
The agency approved vandetanib in April but AstraZeneca chose to launch the drug without waiting for a brand name approval" because there were no other FDA-approved medicines available for people with this rare type of thyroid cancer,” said the company's executive director of oncology, Eric Vogel.
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