U.K. grants Akcea's volanesorsen promising innovative medicine designation

Akcea Therapeutics Inc. (NASDAQ:AKCA) said the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted promising innovative medicine (PIM) designation to volanesorsen (IONIS-APOCIIIRx, ISIS 304801) to treat familial chylomicronaemia syndrome (FCS). Volanesorsen is an apolipoprotein C-III (APOCIII; APOC3) antisense inhibitor.

Akcea submitted an MAA to EMA in July and an NDA to FDA in August for volanesorsen to treat FCS (see BioCentury, Aug. 4 & Sept. 1)...