AstraZeneca cancer drug wins marketing approval in US; heart disease treatment approved in US

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Pharma giant AstraZeneca said its cancer drug had been recommended for marketing authorisation in the European Union to treat patients with metastatic pancreatic cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the phase III Polo trial.

The trial demonstrated that the company's cancer drug, Lynparza, nearly doubled the time patients with metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo.

In a separate statement, the company also said heart disease medication, Brilinta, had been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III Themis trial.

The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular events at 36 months with aspirin plus Brilinta 60mg versus aspirin alone in patients with coronary artery disease and type-2 diabetes at high-risk of a first heart attack or stroke, the company said.