Novartis has refiled its application for inclisiran following a complete response letter (CRL) from the FDA last December citing "unresolved" issues at a third-party production facility. On Tuesday, the company said that it listed its own site in Schaftenau, Austria, as the manufacturing location for the final finished product in its resubmission.
The siRNA therapy targeting PCSK9 garnered EU approval in December under the brand Leqvio to treat adults with primary hypercholesterolaemia or mixed dyslipidaemia, but US clearance has been delayed after the FDA flagged issues at the Italian plant of Novartis supplier Corden Pharma. CEO Vas Narasimhan said during an earnings call earlier this year that a response to the CRL was planned for the second or third quarter, but did not give any more details about what the problems were.
Novartis, which reiterated that any issues with the Corden facility were not related to the drug's efficacy or safety, noted that the transfer of inclisiran production to the Austrian site had been planned and initiated in 2020, before the FDA brought up its concerns. The company indicated that the resubmission "addresses" those issues.
Novartis acquired inclisiran last year through its $9.7-billion takeover of The Medicines Company. The Swiss drugmaker added that an update would be provided after the FDA decides whether to accept the resubmission and continue its review.
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