(CercleFinance.com) – Abivax announces today that the FDA (Food & Drug Administration) has approved the pediatric initial study plan (iPSP) for the clinical development of obefazimod for the treatment of chronic inflammatory diseases of the intestine (IBD) in children 2 to 17 years old
Following the ‘End of phase 2’ meeting, Abivax had initiated its phase 3 program (‘ABTECT program’) with obefazimod in adults with moderate to severe ulcerative colitis (UCH), which includes patients aged 16 years and over. more.
For Professor Hartmut J. Ehrlich, CEO of Abivax, the FDA approval represents “an important step for Abivax to establish a comprehensive and consistent approach that includes the adult patient population as well as children and adolescents suffering from of these diseases.
Abivac reports that obefazimod is currently being tested in a Phase 3 clinical program (‘ABTECT program’) in ulcerative colitis with the first patient enrolled in the United States on October 11, 2022.
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