Ebdarokimab by Akeso Gains Approval in China for Psoriasis Treatment

Akeso's Ebdarokimab Approved in China for Psoriasis

Akeso, Inc., a biopharmaceutical company based in Hong Kong, recently celebrated a major milestone with the approval of
Ebdarokimab, an innovative monoclonal antibody, by the National Medical Products Administration (NMPA) in China. This drug is officially authorized for the treatment of moderate-to-severe plaque psoriasis in adult patients, offering a new ray of hope for individuals struggling with this chronic condition.

A Step Forward in Autoimmune Disease Treatment

The approval of Ebdarokimab is particularly significant as it represents the company's first Class 1 new drug targeting autoimmune diseases. Furthermore, it stands as the second non-oncology new drug to receive marketing authorization, coming on the heels of Ebronucimab (PCSK9). This expansion beyond oncology showcases Akeso's commitment to addressing a range of complex health issues.

Ebdarokimab underwent stringent evaluation through five clinical studies encompassing patients in China, highlighting its efficacy and safety. Two pivotal Phase III studies produced compelling results, confirming the effectiveness of Ebdarokimab at both 16 and 52 weeks post-treatment initiation.

Efficacy and Safety in Focus

The clinical trials reported impressive short-term efficacy, with patients who received a 135 mg injection of Ebdarokimab, administered in two doses at weeks 0 and 4, achieving a PASI 75 response rate of 79.4% at the 16-week mark. This indicates a significant reduction in psoriasis symptoms for the majority of participants.

Moreover, long-term maintenance treatment, with injections scheduled every 12 weeks after the initial doses, demonstrated sustained efficacy, with a PASI 75 response rate of 77.9% at week 52. Remarkably, these continuous treatments also led to over a 55% improvement in patients' quality of life by week 16, which further improved to a 65% reduction by week 52.

The data reflects a favorable safety profile as well, with adverse events reported at lower rates compared to placebo. This is encouraging for patients who may be concerned about potential side effects from new medications.

Convenience of Administration

Ebdarokimab's method of administration further enhances its attractiveness; patients need only four subcutaneous injections annually. This convenience is expected to improve treatment adherence and, ultimately, allow for better long-term management of psoriasis.

Expert Insights on Ebdarokimab

Professor Jianzhong Zhang, the lead investigator in the pivotal trials and Director of the Dermatology Department at Peking University People's Hospital, remarked on the consistent data supporting Ebdarokimab's rapid onset and durable efficacy, along with a favorable safety record. He expressed optimism about the potential for enhanced treatment adherence and improved patient quality of life, making Ebdarokimab a cutting-edge option for clinicians and patients alike.

Dr. Yu Xia, the Founder, Chairwoman, President, and CEO of Akeso, emphasized that the company is evolving its approach beyond oncology. With a strengthened pipeline targeting various high-prevalence diseases ranging from autoimmune to neurodegenerative conditions, Akeso is poised for a promising future. Following the successful launches of Ebdarokimab and Ebronucimab, the company is also making progress with other promising candidates like Gumokimab and Mandokimab.

Conclusion

Ebdarokimab marks a landmark achievement for Akeso and represents a critical advancement in the fight against psoriasis. By effectively targeting the underlying inflammatory processes associated with skin conditions and offering a user-friendly administration regimen, Akeso is paving the way for better treatment outcomes and heightened quality of life for patients. As the company continues to innovate and expand its drug portfolio, the future looks bright for those affected by autoimmune diseases.