Fourth FDA Breakthrough designation for AbbVie's Imbruvica

US pharma company AbbVie (NYSE: ABBV) said today that the US Food and Drug Administration has granted a fourth Breakthrough Therapy designation (BTD) for Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

The FDA also granted the therapy Orphan Drug designation (ODD) for the condition. There are currently no therapies specifically approved for this condition. Just last week the FDA granted Breakthrough Therapy designation for US biotech firm Incyte’s (Nasdaq: INCY) Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease.

Most patients with cGVHD are prescribed glucocorticoids, a systemic steroid treatment that is able to act upon cells throughout the entire body; however, research shows that long-term use of steroids can lead to serious health complications.