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Novartis' Inclisiran Grounded In The US By FDA Inspection Restrictions

 
• By Jessica Merrill

The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.

Storm at the airport. View of the airplane through rain drops.
FDA issued a CRL for Novartis' inclisiran • Source: Shutterstock

The US launch of Novartis AG' blockbuster hopeful inclisiran has been hung up by COVID-19-related manufacturing inspection delays by the Food and Drug Administration. Inclisiran is one of several potential new drug approvals that have been delayed at the FDA this year because agency officials are unable to inspect facilities due to COVID-19 safety protocols and travel restrictions.

The FDA issued a complete response letter for inclisiran on 18 December just as Novartis was gearing up for a big US launch of the cholesterol-lowering medicine. Inclisiran is a first-in-class small interfering RNA (siRNA) treatment targeting PCSK9 for high cholesterol that Novartis gained last year through the $9.7bn acquisition of The Medicines Company

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