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  34957 of 34981  at  1/26/2021 5:45:57 PM  by

Steve_382


 In response to msg 34933 by  Steve_382
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Re: Bit of a delay on Inclisiran due to unresolved facility inspection - Q2 to Q3 response planned

 A bit longer than I expected.
 
Leqvio
Received EC approval for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. Leqvio is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol (LDL-C) lowering treatment in Europe. Novartis received a CRL from the FDA due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe. The FDA has not raised any concerns related to the efficacy or safety of inclisiran. Response to CRL planned to be submitted Q2 - Q3 2021.
 


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Msg # Subject Author Recs Date Posted
34976 Re: Bit of a delay on Inclisiran due to unresolved facility inspection - Q2 to Q3 response planned Steve_382 0 4/28/2021 12:10:29 PM


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