FDA stiff arms Novartis in a surprise setback for their PCSK9 drug inclisiran
Novartis is not getting an expected approval for inclisiran after all. At least, not this year.
The pharma giant announced Friday evening that the agency has handed out a CRL for the PCSK9 drug from Alnylam, which was widely expected to get approved and go on to shake up that segment of the market.
According to Novartis, the FDA said it wasn’t able to hit their December 23rd PDUFA date due to “unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days.”
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