China-based Akeso Biopharma (HKG: 9926) has announced that the New Drug Application (NDA) for its monoclonal antibody ebdarokimab (AK101), which targets IL-12 and IL-23, has been accepted for review by the Center for Drug Evaluation (CDE) in China. The drug is intended for the treatment of moderate to severe plaque psoriasis.
AK101: A Potential Game-Changer in Psoriasis Treatment
AK101, designated as a “national major novel drug preparation special drug,” is under development for the treatment of a range of conditions including psoriasis, Crohn’s disease, ulcerative colitis, and lupus. It joins a class of drugs similar to Johnson & Johnson’s ustekinumab, which has already received approval in the US and China.
Clinical Studies Support AK101’s Efficacy and Safety
AK101 is supported by five clinical studies, with two pivotal Phase III studies providing key efficacy and safety data for AK101 in patients with moderate to severe plaque psoriasis at 16 weeks and 52 weeks. The results demonstrated significant efficacy and good safety of AK101 in treating moderate to severe plaque psoriasis over both time periods, effectively improving patients’ quality of life and skin lesions.-Fineline Info & Tech
