China’s NMPA accepts Akeso’s NDA for ebronucimab

China’s National Medical Products Administration (NMPA) has accepted Akeso’s new drug application (NDA) for ebronucimab (AK102) for two indications.

Ebronucimab is intended to treat heterozygous familial hypercholesterolemia (HeFH), primary hypercholesterolemia and mixed hyperlipidemia.

It is a fully human anti-PCSK9 monoclonal antibody co-developed by the company and AD Pharmaceuticals.

The new drug marketing application was based on four pivotal Phase III trials, including one conducted in HeFH patients and three in primary hypercholesterolemia and mixed hyperlipidemia patients.

All three dosing regimens were effective with statistical and clinical significance following 12-week treatment in primary hypercholesterolemia and mixed hyperlipidemia, and in HeFH patients.

The lipid-lowering efficacy was maintained over a 52-week long-term treatment in both indications, demonstrating ebronucimab’s ability to offer consistent and lasting benefit to patients. 

Ebronucimab treatment also significantly increased HDL-C and ApoA-I levels, and reduced TC, non-HDL-C and ApoB levels.

Akeso noted that the long-term stable treatment with its monoclonal antibody is anticipated to achieve greater cardiovascular benefit.

Ebronucimab has also demonstrated an advantageous safety profile and there is no significant variance in safety outcomes in the aged population.

In January 2023, China’s NMPA granted marketing approval to Akeso’s penpulimab in combination with chemotherapy as the first-line treatment for locally advanced or metastatic squamous non-small cell lung cancer.