Sobi announces FDA approval of Doptelet for pediatric thrombocytopenia patients

FDA Approval: Sobi North America received FDA approval for Doptelet to treat thrombocytopenia in pediatric patients aged one year and older with chronic immune thrombocytopenia, including a new formulation for children under six years old.

Study Results: The approval was based on the AVA-PED-301 study, which demonstrated that 27.8% of patients treated with Doptelet achieved a durable platelet response, while common adverse reactions included viral infections and nasopharyngitis.