Shots:
- The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China
- Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week safety follow-up or long-term extension period. Trail met its 1 & 2EPs, Presented in the ASH’24 & published in the Blood
- Wayrilz is a BTK inhibitor for ITP, targeting the disease’s root cause through multi-immune modulation. It’s approved in the U.S. for adults with persistent or chronic ITP unresponsive to prior treatment
Ref: Sanofi | Image: Sanofi | Press Release
Related News:- Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)
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