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Novartis suspends production of radioligand therapy medicines

DTMT Network

Swiss pharmaceutical giant Novartis has announced recently that the company is temporarily suspending production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey.

In a statement, the company said that it has taken this action out of an abundance of caution as it addresses potential quality issues identified in its manufacturing processes.

Novartis said that it is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks.

The move will lead to the suspension of delivery of  Lutathera and Pluvicto in the US and the Canadian markets, though some doses of Lutathera will be available in Europe and Asia, although there might be some delay in supply, Novartis informed.

Additionally, Novartis informed that it is putting a temporary hold on screening and enrolment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.

“Quality and patient safety are our top priorities. There is currently no indication of any risk to patients from doses previously produced at these sites. Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety,” the statement by Novartis read.

“We recognise that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible. Health authorities have been informed and will receive additional updates as they are available,” Novartis said.

 


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