Latest 6-K filing from NVS shows not much change on the Inclisiran approval (see below), but they are pushing for a very broad label with another study currently in P3, but takes time to prove the cardio benefits:
Secondary prevention of cardiovascular
events in patients with elevated levels of LDL-C
Leqvio (inclisiran) received EC approval in December 2020, for the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet. In the US, a CRL was received due to unresolved third party facility inspection-related conditions. We expect to submit our response to the CRL in Q2-Q3 2021. Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.