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Incyte Announces U S Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease

Incyte Announces U S Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease
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United statesAmerican association of hematology annual meetingExchange commissionAmerican society of hematology annual meetingSyndax pharmaceuticals nasdaqDrug administrationPriority reviewBiologics license applicationPrescription drug user fee actPlenary scientific sessionAmerican societyHematology annual meetingSyndax pharmaceuticalsChief executive officerAmerican associationOrphan drug designation

Incyte Announces U S Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease

- Priority Review acceptance based on positive results of AGAVE-201 study .

United statesAmerican association of hematology annual meetingSyndax pharmaceuticals nasdaqExchange commissionAmerican society of hematology annual meetingDrug administrationPriority reviewBiologics license applicationPrescription drug user fee actPlenary scientific sessionAmerican societyHematology annual meetingSyndax pharmaceuticalsChief executive officerAmerican associationOrphan drug designation

Incyte Announces U S Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease

Incyte today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD).

United statesDrug administrationAmerican society of hematology annual meetingAmerican association of hematology annual meetingProduct serviceExchange commissionSyndax pharmaceuticals nasdaqDrug administration grants priority review for axatilimabDrug administration grants priority reviewChronic graft versus hostPriority reviewBiologics license applicationPrescription drug user fee actPlenary scientific sessionAmerican societyHematology annual meeting

Axatilimab Shows Efficacy in Recurrent/Refractory GVHD

Highest overall response rate and least toxicity seen with lowest dose

United statesDaniel wolffMike bassettUniversity hospital of regensburgAmerican society of hematologyDevelopers syndax pharmaceuticalsUniversity hospitalAmerican societyModified lee symptomSyndax pharmaceuticals

Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease

WILMINGTON, Del. & WALTHAM, Mass. (BUSINESS WIRE) Dec 10, 2023

United statesSan diegoKaplan meierMichaela metzgerSharon klahreDaniel wolffPabloj cagnoniExchange commissionDrug administrationHead of researchCompany on twitterProfessor at university hospital regensburgSyndax pharmaceuticals nasdaqSyndax pharmaceuticalsAmerican society of hematology annual meetingDevelopment incyte

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