Novartis to manufacture anti-cholesterol drug Leqvio for US in Austria due to delay in US clearance

Novartis will manufacture anti-cholesterol drug Leqvio at its own plant in Austria to supply the US as it seeks US approval that has been delayed by regulatory concerns over a contractor’s Italian facility.

Leqvio, which cost Novartis $10 billion in a 2019 acquisition, has been approved in Europe but US clearance stalled after the Food and Drug Administration (FDA) questioned “unresolved facility inspection-related conditions” at the Italian plant of Novartis supplier Corden Pharma.

Novartis said in a statement that it has issued a resubmission to the FDA’s so-called “complete response letter” in which it listed “its own site in Schaftenau, Austria, as the manufacturing location for the final finished product”.

The medicine’s generic name is inclisiran.

“We are manufacturing inclisiran at Schaftenau and with Corden,” a spokesperson for Novartis said. “Corden continues to supply our markets outside the US and Schaftenau will supply the US.”

Vas Narasimhan, Chief Executive Officer, Novartis has said that Leqvio, bought from The Medicines Co. to augment its heart-drug portfolio, could become one of the Swiss drugmaker’s biggest sellers ever.

Narasimhan had previously said the FDA’s final sign-off for Leqvio was out of the company’s control.

Novartis, which reiterated that any issues with Corden’s plant had nothing to do with Leqvio’s efficacy or safety, added that the transfer of manufacturing to Austria had been planned and began in 2020 before the FDA raised concerns.

The US delay for Leqvio has weighed on Novartis’s sales growth, which was already being crimped by the pandemic. And a big study of the drug in Britain has been pushed back as COVID-19 disrupted the clinical trial.