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

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, 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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