Akcea cutting workforce by 10% after Waylivra CRL

Akcea Therapeutics Inc. (NASDAQ:AKCA) will reduce its workforce by about 10% following receipt of a complete response letter from FDA for Waylivra volanesorsen to treat familial chylomicronemia syndrome (FCS). Akcea announced the CRL on Aug. 27 (see “Delay for Akcea’s Volanesorsen”).

At the Wells Fargo Healthcare Conference in Boston on Sept. 5, Akcea CEO Paula Soteropoulos said the CRL raised concerns regarding management of thrombocytopenia and Akcea’s unexpected proposal for a new dosing and platelet monitoring strategy in its NDA for Waylivra. The company proposed varying dosage by body weight and that platelets be monitored every other week, a paradigm which had not been used in the compound's clinical trials. Soteropoulos said Akcea is using the new dosing and monitoring in its open-label and expanded access programs for Waylivra, but the company needs to request a meeting with FDA to gain clarity on the number of patients and length of treatment the agency will require for resubmission...