New analysis shows inclisiran consistency in LDL-C reduction as Novartis readies for FDA decision
As the FDA continues its review of the former-The Medicines Company, now-Novartis candidate inclisiran ahead of an expected PDUFA before the year is out, the Swiss pharma released pooled data that it hopes bolsters the case for approval.
A post-hoc analysis of two Phase III inclisiran trials showed consistency in efficacy and safety among patients with both hyperlipidemia and atherosclerotic cardiovascular disease despite statin therapy, with 99% of patients showing greater than 30% placebo-adjusted reduction in LDL-C levels. The average reduction was 54.1% from baseline in the 2,300 individuals between the two studies.
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