Gilead’s Magrolimab Mostly Back On Track As FDA Lifts AML, MDS Holds
The clinical holds, initially announced in January, raised concerns about the company losing its edge in CD47-targeting drugs. Partial holds on the DLBCL and myeloma programs remain in place.
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FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.
Gilead’s novel immune checkpoint inhibitor candidate, magrolimab, has been placed on a partial clinical hold by the US Food and Drug Administration in acute myeloid leukemia, adding to a spate of recent setbacks for the therapy that are chipping away at investor confidence.
While the myelodysplastic syndrome trial news seems unlikely to read through to other programs, MDS may have been the drug’s biggest market.