Groundbreaking Rare Disease Drug Approval (OGSIVEO [nirogacestat]) Propelled by Expert Regulatory Strategy and Program Management

Rare Disease Drug Approval (OGSIVEO [nirogacestat])

SpringWorks Therapeutics, a biopharmaceutical company that applies a precision medicine approach to developing and delivering life-changing medicines, acquired Pfizer’s asset to begin their pivotal clinical study in desmoid tumors. They needed to refine their late-stage regulatory strategy considering Pfizer’s previous development (plus compelling results from an investigator-initiated trial putting them at End of Phase 2 (EOP2)), define a clear development roadmap to approval, and submit a New Drug Application (NDA). Halloran provided team direction to collaborate through a shared vision and alignment. Read our case study, written in collaboration with our colleagues at SpringWorks.