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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 [1], 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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