HUTCHMED Reports NDA Acceptance with Priority Review by the US FDA for Sovleplenib to Treat Primary Immune Thrombocytopenia (PIT)
Shots:
- The NDA was submitted based on data from the P-III (ESLIM-01) clinical trial evaluating the safety & efficacy of Sovleplenib vs PBO in patients (n=188) with primary ITP
- As per the results the study met its 1EP by depicting a clinically meaningful & statistically significant increase in DRR in patients treated with Sovleplenib vs PBO. Moreover, the 2EPs of response rate & safety were also met
- Sovleplenib is a selective inhibitor of Syk, a major component in B-cell receptor & FcR signalling & is a target for the treatment of multiple subtypes of B-cell lymphomas & autoimmune disorders
Ref: HUTCHMED | Image: HUTCHMED
Related News:- HUTCHMED Reports P-III Trial (ESLIM-01) Results of Sovleplenib for Primary Immune Thrombocytopenia in China
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
