Last Two Of Three Big Inclisiran Studies Boosts The Medicines Co.
Filings for the twice-yearly anti-PCSK9 injection under a partnership with Alnylam are on track, including a fourth quarter submission in the US. Detailed ORION-9 and ORION-10 data will be presented at AHA in November.
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US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.
Looking to be a game-changer with a highly effective LDL-C-lowering agent dosed twice annually, The Medicines Company says inclisiran met efficacy endpoints in a large Phase III study. But observers await fuller data, including safety details.
ODYSSEY Outcomes data added to US label for Praluent; update includes claim for reduced cardiovascular incident risk and trial data indicating an all-cause mortality benefit.