1st Jun 2020 08:38
(Alliance News) - AstraZeneca PLC on Monday said Brilinta has received US approval as a treatment to reduce the risk of stroke, as it reported progress in the EU for its Lynparza cancer drug.
The FTSE 100-listed pharmaceutical company said Brilinta - or ticagrelor - was approved by the US Food & Drug Administration as a treatment to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.
The approval from the regulatory body was based on results from the phase three THEMIS trial which showed Brilinta plus aspirin reduced the relative risk of cardiovascular death, heart attack, or stroke by 10%, compared with aspirin alone in patients with coronary artery disease and type-2 diabetes at high-risk of a first heart attack or stroke.
"Today's approval of Brilinta is important news for patients with coronary artery disease who will 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," said Ruud Dobber, executive vice president of AstraZeneca's BioPharmaceuticals Business Unit.
Separately, Astra said Lynparza - or olaparib - has been recommended for marketing authorisation in the European Union for the 1st-line maintenance treatment of patients with germline BRCA-mutated metastatic pancreatic cancer.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its opinion on results from the Phase III POLO trial which found that Lynparza almost doubled the time in which patients lived without disease progression or death compared to placebo.
"Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU," said Jose Baselga, executive vice president of Research & Development Oncology at Astra.
Lynparza is being co-developed and co-commercialised with US drug maker Merck & Co Inc.
Astrazeneca shares were trading 1.6% higher at 8,717.00 pence each on Monday morning in London.
By Ife Taiwo; [email protected]
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