Priority review for Shire's HAE prophylactic

FDA accepted and granted Priority Review to a BLA for lanadelumab (SHP643) from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent hereditary angioedema (HAE) attacks in patients ages 12 and older. Its PDUFA date is Aug. 26.

The human mAb against plasma kallikrein (KLKB1) significantly reduced monthly HAE attack rates vs. placebo in the Phase III HELP trial, meeting the study's primary endpoint. Shire obtained lanadelumab via its 2016 acquisition of Dyax Corp., whose shareholders are eligible for a contingent value right (CVR) worth $646 million if FDA approves the candidate by YE19 (see BioCentury, May 19, 2017)...