AstraZeneca gets EU approval for Axanum; Merck & Co files ridaforolimus with EMA

Anglo-Swedish drug major AstraZeneca (LSE: AZN) revealed this morning that it has received approval in 23 European Union member states and Norway for Axanum, a fixed dose combination of 81mg low-dose ASA (acetylsalicylic acid; aspirin) and 20mg esomeprazole.

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 aspirin is recommended mainstay therapy for patients with high-risk for cardiovascular events, but around a third are also at increased risk of stomach ulcer and gastrointestinal bleeding. In fact, the most common reason for stopping low-dose ASA treatment is upper gastrointestinal problems, AstraZeneca explains. 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, meaning it has the potential to provide continuous CV protection in this patient population, the drugmaker said.

The EU decision took place under the decentralized procedure (DCP), with Germany acting as reference member state. This process is now followed by national approvals and local pricing and reimbursement discussions.