FDA Approves Grafapex for AML/MDS
Medexus was informed that the FDA approved Grafapex, an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Grafapex holds Orphan Drug Designation under the Orphan Drug Act, meaning that the product will benefit from up to seven-and-a-half years of regulatory exclusivity in the FDA-approved indication. Medexus holds exclusive commercial rights to Grafapex in the United States under a February 2021 exclusive license agreement with medac GmbH.
"We are pleased to report this positive development, which marks a strategically important step forward for our business and, importantly, will now benefit eligible patients across the United States," commented Ken d'Entremont, Medexus's Chief Executive Officer. "Not only will Grapafex make a substantial contribution to alloHSCT in the United States, but it also solidifies Medexus's leadership position in this therapeutic field."
Medexus holds exclusive commercial rights to Grafapex in the United States under a February 2021 exclusive license agreement with medac GmbH.
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