The U.S. Food and Drug Administration approved AbbVie Inc.'s Imbruvica to treat adult patients with chronic graft-versus-host-disease who failed one or more treatments.
With this approval, Imbruvica is the first and only therapy specifically approved for adults with chronic graft-versus-host-disease, a serious and debilitating potential consequence of stem cell or bone marrow transplant.
The approval was based on the results of a phase 1b/2 trial where 67% of patients who received the treatment saw improvements in their symptoms. Also, 48% of the patients experienced sustained response for at least 20 weeks.
Imbruvica is jointly developed and commercialized by AbbVie's Pharmacyclics LLC and Janssen Biotech Inc., a Johnson & Johnson company. The companies are continuing the drug's clinical development, including phase 3 studies evaluating it in multiple disease areas.