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Issues at Italian CDMO leads to US approval delay for Novartis’ inclisiran

Posted By On In Biotech (General),Contract Manufacturing | Comments Disabled
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he US FDA has issued a complete response letter for Leqvio (inclisiran) due to ‘unresolved facility inspection-related conditions’ at a third-party site run by Corden Pharma.

In October 2020 [5], this publication reported the US approval of Novartis’ small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, Leqvio, was dependent on a regulatory inspection at a third-party manufacturer in Italy.

While Novartis spoke of regulatory delays of up to five months caused by COVID-19, it said it was confident of maintaining the US Food and Drug Administration (FDA) action date of December 23.

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Author: Canan Schuman, PharmD/PhD [7]

Canan Schumann is Chief Editor for Axxiem and for Axxiem's blog "BiotechOntheWeb". When not writing for Axxiem, Canan works as a Clinical Research Scientist II at the Research and Development Department at Molecular Testing Labs, developing endpoint assays for the detection of infectious disease and cancer. Canan currently resides in Portland, Oregon, where he received his Honors Bachelor of Science (HBS), Doctor of Pharmacy (PharmD.), and his Doctor of Philosophy (Ph.D.) in Biopharmaceutics at Oregon State University.