FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now

On Friday afternoon, Novartis (NYSE: NVS) gave investors some bad news regarding an experimental treatment the pharma giant bought for around $9.7 billion last December. Instead of issuing an approval decision for inclisiran, the FDA sent Novartis a complete response letter (CRL) due to an unresolved facility inspection issue.

Earlier this month, the European Commission granted inclisiran approval to treat just about anyone with high cholesterol or mixed dyslipidemia under the brand name Leqvio. Unfortunately, the COVID-19 pandemic made it impossible for the FDA's inspectors to evaluate a European manufacturing site included in the application.

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Source Fool.com