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AbbVie, J&J's Imbruvica gets FDA approval for chronic graft versus host disease

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.