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AstraZeneca clears regulatory hurdles with 'Brilinta' and 'Lynparza'

By Josh White

Date: Monday 01 Jun 2020

AstraZeneca clears regulatory hurdles with 'Brilinta' and 'Lynparza'

(Sharecast News) - AstraZeneca announced on Monday that 'Brilinta', or ticagrelor, has been approved in the United States to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD) - the most common type of heart disease.
At the same time, it announced alongside its partner MSD that 'Lynparza', or olaparib, has been recommended for marketing authorisation in the European Union (EU) for the first-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

The FTSE 100 pharmaceuticals giant said that the approval of Brilinta by the US Food and Drug Administration (FDA) was based on positive results from the phase 3 'THEMIS' trial.

That trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular events at 36 months with aspirin plus Brilinta 60mg, compared to aspirin alone in patients with CAD and type-2 diabetes at high-risk of a first heart attack or stroke.

The primary composite endpoint was driven by a reduction in heart attack and stroke.

It was the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high cardiovascular risk, but without a history of heart attack or stroke.

"Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people," said Deepak Bhatt, the co-chair of the THEMIS trial, executive director of interventional cardiovascular programmes at Brigham and Women's Hospital, and a professor of medicine at Harvard Medical School in Boston.

"The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients."

Ruud Dobber, executive vice-president, of AstraZeneca's biopharmaceuticals business unit, said today's approval of Brilinta was "important news" for patients with coronary artery disease, who would now have a new therapy option to reduce the risk of a first heart attack or stroke.

"This new indication is a further testament to the overwhelming science supporting Brilinta in the management of patients with coronary artery disease at high risk for cardiovascular events."

The company added that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion of Lynparza on results from the phase 3 'POLO' trial, published in the New England Journal of Medicine.

It said the trial demonstrated that Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months, compared to 3.8 months on placebo.

The safety and tolerability profile of Lynparza in the POLO trial was consistent with previous trials.

"Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades," said executive vice-president of oncology research and development José Baselga.

"We are now one step closer to bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU."

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