Posted by Michael Wonder on 05 Jun 2023
NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two cardiovascular indications
1 June 2023 - Akeso announced today that China's NMPA has accepted its new drug application for its fully human anti-PCSK9 monoclonal antibody ebronucimab for two indications:
- Primary hypercholesterolaemia and mixed hyperlipidaemia
- Heterozygous familial hypercholesterolaemia.
Ebronucimab is jointly developed by Akeso and AD Pharmaceuticals (a joint venture with Akeso).
The new drug marketing application for ebronucimab is based on four pivotal Phase 3 studies, including three pivotal studies in patients with primary hypercholesterolaemia and mixed hyperlipidaemia and one pivotal study in patients with heterozygous familial hypercholesterolaemia.
