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

Global Blood Therapeutics Inc 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.