Shots:
- FDA has approved Wayrilz for adults with persistent or chronic ITP who did not respond adequately to prior therapy following approval in UAE in Jun 2025; Application under the EMA & NMPA’s review
- Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over 12wks., after which 64% vs 32% achieving durable platelet count continued for 24wks., followed by 28wk. OLE & 4wk. safety follow-up; study is ongoing in adolescents
- Trial met its 1 & 2EPs, showing sustained platelet response at 25wks. (23% vs 0%), faster onset (36 days vs not reached), & longer duration (7 vs 0.7wks.). Pts also achieved a 10.6-point QoL improvement vs 2.3 per ITP Patient Assessment Questionnaire; data was presented at ASH’24
Ref: Sanofi | Image: Sanofi | Press Release
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