PAFSC advisory committee in Japan recommends Jakavi for post-transplant graft-versus-host disease
Novartis Pharma’s JAK inhibitor Jakavi (ruxolitinib) passed a review by a key health ministry advisory panel for its label expansion into post-transplant graft-versus-host disease (GVHD)
The Pharmaceutical Affairs and Food Sanitation Council’s First Committee on Drugs, a de-facto decision-making body for marketing approval, recomended Jakavi for an additional indication of GVHD after hematopoietic stem cell transplantation (HSCT) in cases ineffectively treated with steroids. The drug is currently approved for myelofibrosis and polycythemia vera.As a condition for approval for Jakavi, Novartis will be required to conduct post-marketing database surveillance using registries. The product has been designated as an orphan drug for this indication.
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