FDA Approval of Axatilimab Marks New Era in Chronic GVHD Treatment
• Axatilimab, a CSF1R-blocking antibody, received FDA approval in August 2024 for chronic graft-versus-host disease treatment, demonstrating a 74% overall response rate in clinical trials.
• Novel therapies including baricitinib, ixazomib, and teduglutide show promising results in treating steroid-refractory GVHD, offering new hope for patients resistant to conventional treatments.
• Pharmacists play a crucial role in GVHD management through medication monitoring, patient education, and therapeutic drug optimization, contributing to improved patient outcomes.
FDA Issues Warning to Sanofi for API CGMP Deviations; Clinical Hold Placed on Atara Biotherapeutics
• The FDA issued a warning letter to Sanofi, citing significant deviations from CGMP standards at its Genzyme facility, potentially leading to regulatory actions.
• Atara Biotherapeutics faces a clinical hold on its IND applications, including Ebvallo and ATA3219, due to GMP compliance issues at a third-party manufacturing site.
• Atara Biotherapeutics is collaborating with the FDA to address the issues and aims to submit the necessary data for the release of the clinical hold, prioritizing patient safety.
• Sanofi's partnership with Scribe Therapeutics reached a milestone, potentially earning Scribe over $1.2 billion, while Atara's Ebvallo received EMA clearance for testing at a FUJIFILM facility.
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