By Anthony O. Goriainoff

AstraZeneca PLC said Monday that Brilinta has been approved in the U.S. to reduce the risk of a first heart attack or stroke, and that Lynparza has been recommended for marketing authorization in the EU for patients with metastatic pancreatic cancer.

The U.K. drug maker said the U.S. Food and Drug Administration based its approval on positive results from the phase III THEMIS trial.

The pharmaceutical company also said the EU marketing authorization is for the first line treatment of patients with germline BRCA-mutated metastatic pancreatic cancer. The European Medicines Agency based its decision on results from the phase III POLO trial which showed Lynparza nearly doubled the time patients with germline BRCA-mutated metastatic pancreatic cancer lived without disease progression to a median of 7.4 months, versus 3.8 months for those on a placebo.

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

(END) Dow Jones Newswires

June 01, 2020 02:43 ET (06:43 GMT)