Q2 2021 Results - Reimagining Medicine
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
Inclisiran resubmission of NDA filed with FDA-
PDUFA action date Jan 1, 2022
◉
◉
Own site in Schaftenau (Austria) listed as the manufacturing location for finished product within
resubmission
Resubmission addresses the FDA Complete Response Letter (CRL) issued in December 2020,
stating unresolved facility inspection-related conditions at a third-party manufacturing facility
FDA did not raise any concerns related to the efficacy or safety of inclisiran
The transfer of the manufacturing of inclisiran (finished product) to the Novartis-owned facility at
Schaftenau was planned and initiated in 2020, prior to the receipt of the CRL
◉
Class 2 Resubmission, PDUFA action date Jan 1, 2022
11 Investor Relations | Q2 2021 Results
3
INNOVATION
NOVARTIS | Reimagining MedicineView entire presentation