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Global Blood Submits US Application For Expanded Use Of SCD Drug, Oxbryta, In Patients Aged 4-11 Years

·1 min read
  • Global Blood Therapeutics Inc (NASDAQ: GBT) has submitted a supplemental marketing application to the FDA seeking accelerated approval for Oxbryta (voxelotor) for the treatment of Sickle Cell Disease (SCD) in children ages 4 to 11 years.

  • The Company also filed a related separate application seeking approval for a pediatric weight-based formulation of Oxbryta.

  • Additionally, GBT initiated two pivotal Phase 3 trials of inclacumab, a novel P-selectin inhibitor.

  • The Phase 3 trials will evaluate the safety and efficacy of inclacumab for vaso-occlusive crises (VOCs) associated with SCD.

  • Both studies are enrolling individuals with SCD age 12 years and older who have experienced between two and 10 VOCs in the previous year.

  • The Company has also enrolled the first SCD patient in a Phase 1 study evaluating GBT021601 (GBT601), a next-generation hemoglobin S (HbS) polymerization inhibitor.

  • This single and multiple ascending dose Phase 1 study assesses the safety, tolerability, pharmacokinetics, and pharmacodynamics of GBT601 in up to six people with SCD ages 18 to 60 years.

  • Price Action: GBT shares are down 1.26% at $30.16 during the market session on the last check Thursday.

  • Related content: Benzinga's Full FDA Calendar.

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