EMA accepts MAAs for olaparib, naloxegol
AstraZeneca plc (LSE:AZN; NYSE:AZN) said EMA accepted for review an MAA for olaparib as maintenance treatment of platinum-sensitive relapsed serous ovarian cancer in patients with breast cancer early onset (BRCA) mutations. The MAA is based on the Phase II Study 19, in which a retrospective analysis from a subgroup of patients with BRCA mutations showed that olaparib significantly improved median progression-free survival vs. placebo in patients with germline BRCA mutations (11.2 vs. 4.1 months, p<0.001). The poly(ADP-ribose) polymerase (PARP) inhibitor is in Phase III testing for the indication.
Seperately, AstraZeneca said EMA accepted for review an MAA for naloxegol to treat opioid-induced constipation (OIC). The acceptance triggered a $25 million milestone payment to partner Nektar Therapeutics (NASDAQ:NKTR) under an amended 2009 deal that granted the pharma exclusive, worldwide rights to the product. Earlier this month, Nektar disclosed that AstraZeneca submitted an NDA to FDA for naloxegol to treat OIC. The product is a PEGylated form of naloxol, a peripheral mu opioid receptor ( OPRM1; MOR) antagonist (see BioCentury Extra, Sept. 17). ...