The Medicines Co. is aiming to file for US and EU approval of its novel PCSK9 inhibitor inclisiran in the second half of 2019, following an "aggressive and thoughtful" Phase III program emboldened by updated data from the Phase II ORION-1 study.
Medicines Company Gets Aggressive With Inclisiran Phase III Plans
Updated ORION-1 data presented at the European Society of Cardiology have encouraged The Medicines Company to take an "aggressive" approach to its Phase III plans for the novel PCSK9 synthesis inhibitor.
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