Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer
AstraZeneca ends CV outcomes trial of Epanova
AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed dyslipidemia at high risk of CV disease. Epanova is an ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The discontinuation removes from development a potential competitor to another fish oil-derived therapy, Vascepa icosapent ethyl from Amarin Corp. plc (NASDAQ:AMRN); that company’s shares added $0.80 to $19.75 Monday.
Priority Review for Lynparza combo in new setting
In more auspicious news for AstraZeneca, FDA accepted its sNDA for Lynparza olaparib plus Avastin bevacizumab as first-line maintenance treatment for ovarian cancer. The agency will assess the combo under Priority Review, with a PDUFA date next quarter. The doublet reduced the risk of disease progression or death in the Phase III PAOLA-1 study (see “ESMO Readout Could Extend Lynparza’s Reach”)...