Novartis says transferring the manufacturing of Leqvio (inclisiran) to its own site in Austria is not related to documentation issues at its CDMO.
Novartis reported its Q4 financials this week, detailing that it is working with the US FDA to minimize further delays in the approval of siRNA therapy, Leqvio.
While the therapy has been approved in Europe, a complete response letter (CRL) received in December highlighted problems at contract development manufacturing organization (CDMO) CordenPharma in Italy.
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Novartis now hopes to resubmit in Q2-Q3 2021 while simultaneously transferring tech to its own facility.
“We are concurrently working on a tech transfer to add our own Novartis facility in Entresto now for the production supply chain of Leqvio,†CEO Vas Narasimhan told shareholders during a conference call.
Entresto (sacubitril/valsartan) is a fixed-dose combination medication for use in heart failure and according to a spokesperson for Novartis it manufactured at multiple sites.
“The transfer of the manufacturing of inclisiran to a Novartis-owned facility (Schaftenau, Austria) has been planned since the acquisition and is not related to the CRL,†they told BioProcess Insider, adding “Novartis is currently working on the manufacturing transfer protocols to ensure a smooth transfer.â€
CDMO and timelines
At the time of the CRL, Novartis did not divulge the issues at CordenPharma and was unable to detail a new approval timeline.
However, on the call Narasimhan said it was “primarily related to documentation and controls†at the CDMO, and hopes to resubmit to the FDA in the Q2-Q3 time period.
“The FDA had originally planned to inspect this facility in May of 2020. They are currently not conducting overseas inspections,†said Narasimhan.
Last year, we reported on the COVID-related regulatory delay that the Italian drug product plant faced. This is an ongoing issue for Novartis. According to Narasimhan, overseas FDA inspections cannot happen “in situations like this,†which leaves an inspection date unknown.
For the full year 2020, Novartis reported total sales across its Innovative Medicines division of $39 billion, up 3% year-on-year. Total sales for the year stood at $47 billion.