Novartis shifts Leqvio manufacturing to Austrian facility

Pharma firm tells FDA tech transfer to its own facility in Schaftenau, Austria is underway after regulator highlighted concerns about third party CDMO site in Italy

Novartis said on Tuesday it has moved manufacturing of its anti-cholesterol treatment Leqvio (inclisiran) to its own facility at Schaftenau, Austria in a bid to seal US Food and Drug Administration approval after the process was delayed by the regulator’s concerns over a third party contractor’s site.

The FDA sent the pharma company a ‘complete response’ letter in December 2020, stating “unresolved facility inspection-related conditions” at CDMO Corden Pharma’s site in Italy. Novartis said the FDA did not raise any concerns related to the efficacy or safety of Leqvio.

Novartis said in a statement that in response to the FDA’s letter, it had issued a resubmission in which it named the Schaftenau facility “as the manufacturing location for the final finished product.”

The company added that the tech transfer of the Leqvio manufacturing to Schaftenau was planned and initiated in 2020, even before the FDA pushed back on the new drug application.

Blockbuster hopeful Leqvio has already been approved by the European Medicines Agency and the Corden Pharma site will continue to supply ex-US markets while Schaftenau will serve the US market.

Novartis said it will provide an update after the FDA has determined that the response resubmission is complete.

The company added Leqvia to its heart-drug portfolio in 2019 when it acquired The Medicines Co. for $9 billion.