China’s NMPA approves Akeso’s gumokimab for plaque psoriasis

The approval is based on data from one pivotal Phase III trial (AK111-301) and three additional supportive studies.

Study results showed that gumokimab delivered rapid and strong efficacy.

At week 12 of the Phase III trial, gumokimab achieved a Psoriasis Area and Severity Index 75 (PASI 75) response rate of 94.6% and a complete skin clearance rate (PASI 100) of 47.7%, compared with 28.6% for other agents in the same class.

Durable results were seen through week 52, with a PASI 75 response rate approaching 100% and a PASI 100 response rate of 68.9%.

The safety data also showed a favourable profile for gumokimab, with incidences of treatment-emergent adverse events, serious adverse events, and infections listed among the lowest seen in similar trials of IL-17 inhibitors.

The therapy’s subcutaneous regimen requires only 17 injections annually, including the loading phase, approximately half the injection burden mandated by other IL-17 inhibitors.

Huashan Hospital, Fudan University professor Xu Jinhua is the principal investigator of the study.

Akeso founder, chairwoman, president and CEO Dr Xia Yu said: “To better address patients’ diverse needs, Akeso has successfully developed and launched ebdarokimab and gumokimab, two therapies targeting distinct pathogenic pathways that complement each other.

“The autoimmune disease field remains one of the largest and fastest-growing areas in innovative drug development. With these two approvals, we have built a strong, differentiated portfolio for psoriasis.”

The NMPA’s Center for Drug Evaluation (CDE) has accepted a supplemental new drug application for gumokimab in active ankylosing spondylitis.

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