China’s NMPA Accepts NDA for Akeso’s Gumokimab to Treat Moderate to Severe Psoriasis
Shots:
- China’s NMPA has accepted an NDA for gumokimab (AK111) to treat mod. to sev. plaque psoriasis based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks.
- Data showed short-term efficacy, with a PASI 75 response rate approaching 96% & an sPGA 0/1 response nearing 90%. PASI 90 hit ~80%, & PASI 100 reached >40%, with 80% patients achieving PASI 90 & ~50% achieving a PASI 100 response at 12wks.
- Also, Gumokimab showed long-term efficacy for over 52wks. with PASI 75 response rate nearing to ~100% with stable sPGA 0/1 rates as well as PASI 90 & PASI 100 response rates improved to ~90% & ~65%, respectively. Safety was favorable
Ref: Prnewswire | Image: Akeso
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
