Shots:
- The US FDA has approved Doptelet to treat thrombocytopenia in pts (≥1yrs.) with persistent or chronic ITP who have not responded to prior treatments. Approval also incl. a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for children (1-6yrs.)
- Approval was based on P-III (AVA-PED-301) study assessing Doptelet in pediatric ITP pts, which showed that 27.8% of Doptelet pts achieved the 1EP of durable platelet response vs 0%, 81.5% met the alternative endpoint vs none, & 55.6% vs 16.1% reached ≥50×10⁹/L platelets at Day 8 without rescue therapy
- Doptelet is an oral TPO receptor agonist that boosts platelet production by stimulating megakaryocyte development
Ref: Globenewswire | Image: Sobi | Press Release
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