Despite a tepid response from payers to first approvals in the protein convertase subtilisin/kexin type 9 (PCSK9) drug class, The Medicines Co. (MDCO) plans to move aggressively into a pivotal phase III program for its candidate, inclisiran (formerly PCSK9si and ALN-PCSsc), after reaching agreement with the FDA on a study design to support submission of a new drug application (NDA), expected around year-end 2019.