FDA Clears Addition of Time-based Final Analysis to Pivotal Phase 3 Study of Uproleselan in R/R AML
“We are pleased the FDA cleared the addition of a time-based pathway to final analysis as it provides the opportunity to evaluate the effect of uproleselan on R/R AML based on a clinically mature database with more than three years median follow-up,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “This approach is consistent with regulatory precedent adopted for a prior pivotal AML study for an approved drug and reflects our commitment to science-driven analysis as we seek to deliver uproleselan to R/R AML patients in need of new treatment options as soon as possible.”
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