Novartis to Switch Plants for Resubmission of Heart Drug Leqvio
Novartis has announced that it will manufacture its cholesterol medicine Leqvio (inclisiran) at its own facility in Schaftenau, Austria, instead of the third-party site it was using in Italy, where problems prompted the FDA to reject the drug in December.
The FDA issued a Complete Response Letter (CRL) regarding Leqvio due to what Novartis described as “unresolved facility inspection-related conditions” at the Italian facility. Novartis has resubmitted its application for the drug at the new location rather than making changes at a third-party plant.
Novartis said it was in the process of moving production of the drug to its Austrian facility when the CRL came.
Leqvio had received EU clearance in December with the Italian facility as its manufacturing plant.