Sobi Reports the US FDA’s sNDA Acceptance of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia
Shots:
- The US FDA has accepted the sNDA of Doptelet to treat thrombocytopenia with persistent or chronic ITP in patients (≥1yrs.), not responded well to previous treatments (PDUFA: Jul 24, 2025). Alongside sNDA, NDA for its oral suspension has also been accepted
- sNDA was based on AVA-PED-301 study assessing Doptelet in treating pediatric ITP patients with ≥6mos. duration. It achieved 1EP of durable platelet response (patients achieving ≥6 of 8 weekly platelet counts ≥50×10⁹/L without rescue medication during the last 8wks. of treatment) and alternative 1EP of two consecutive PC ≥50x10^9 /L
- Doptelet is an oral TPO receptor agonist that boosts platelet production by stimulating megakaryocyte development
Ref: Sobi | Image: Sobi
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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.
