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European advisory committee rejects AB Science's masitinib marketing application for mastocytosis; shares down 26%

Published 05/17/2017, 01:36 PM
Updated 05/17/2017, 01:36 PM
© Reuters.  European advisory committee rejects AB Science's masitinib marketing application for mastocytosis; shares down 26%
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a negative opinion regarding AB Sciences' (OTCPK:ABSCF -26.3%) marketing application seeking approval of masitinib for the treatment of adult patients with smoldering or indolent systemic severe mastocytosis who have not responded to other treatments.
  • CHMP was concerned about the reliability of clinical trial results after on-site inspections revealed "serious failings" in the way the study was conducted. Also, major changes were made in the study design while it was in process which made the data difficult to interpret. Safety data were limited and there were concerns about the drug's side effects.
  • The company says it will ask for a re-examination of the application.
  • Masitinib is an orally available tyrosine kinase inhibitor.
  • Now read: Mitsubishi Bags ALS Approval Without Radical Benefit


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