Bit of a delay on Inclisiran due to unresolved facility inspection - Q2 to Q3 response planned | ALNY Message Board Posts


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Msg  34976 of 34981  at  4/28/2021 12:10:29 PM  by

Steve_382


 In response to msg 34957 by  Steve_382
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Re: Bit of a delay on Inclisiran due to unresolved facility inspection - Q2 to Q3 response planned

 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:
 
Leqvio
Secondary prevention of cardiovascular
events in patients with elevated levels of LDL-C
≥2025
3
 
 
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. 


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