Pfizer Continues FDA Approval Expectations for Sickle Cell Disease Therapy Despite Terminating One Phase 3 Trial

1. Pfizer remains optimistic about achieving FDA approval for a sickle cell disease treatment by 2026, despite terminating one of two Phase 3 trials in the THRIVE program.
2. The terminated trial assessed inclacumab, a P-selectin inhibitor monoclonal antibody, due to slow recruitment.
3. Only 72 out of an expected 280 patients were enrolled when the study ended on November 24, 2023.
4. Inclacumab received both orphan drug and rare pediatric disease designations from the FDA for sickle cell disease treatment.
5. Pfizer acquired inclacumab through its acquisition of Global Blood Therapeutics (GBT) in 2022.
6. The remaining active trial in the THRIVE program has a primary readout date set for August 15, 2024.
7. Pfizer also touts Oxbryta, which gained FDA approval in 2019, and GBT021601, a HbS polymerization inhibitor in Phase 2 development, as part of their sickle cell disease portfolio.