Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (SWTUY.PK), Thursday said that the U.S. Food and Drug Administration or FDA has accepted its supplemental New Drug Application (sNDA) for avatrombopag for the treatment of paediatric patients with immune thrombocytopenia.
Immune thrombocytopenia is an autoimmune disorder characterized by low numbers of platelets that results in an increased risk of bleeding.
Prescription Drug User Fee Act (PDUFA) date or a decision from the regulator is expected on July 24, 2025.
The FDA also accepted Sobi's New Drug Application (NDA) for avatrombopag for oral suspension.
The sNDA is based on positive results from the AVA-PED-301 study of avatrombopag for the treatment of pediatric patients with immune thrombocytopenia.
Avatrombopag is already approved by the FDA for the treatment of thrombocytopenia in adults.
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