Can Sanofi Catch Up With Amgen Now That Praluent Has CV Risk-Reduction Claim?
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.
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The battle for PCSK9 inhibitor market share continues with Amgen’s Repatha outselling Praluent, but a now-ended patent dispute no longer threatens Regeneron’s ability to sell its product in the US.
Regeneron advocates industry-FDA collaboration to establish regulatory standards for novel applications of genomic data, such as determining whether long-term outcomes studies are needed, and inclusion of the data in product labeling.
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.