AbbVie Gets Fourth Breakthrough Therapy Designation From FDA For ibrutinib

AbbVie Inc. ABBV revealed that the Food and Drug Administration granted a fourth Breakthrough Therapy Designation (BTD) for its ibrutinib (IMBRUVICA) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. According to the company, the FDA also granted the therapy Orphan Drug Designation (ODD) for the condition.

AbbView said cGVHD is a severe and possibly life-threatening condition in which transplanted cells from the donor attack the patient's body. As a result, Patients might develop this common complication after undergoing allogeneic stem cell or bone marrow transplantation in which they get cells from a donor. The company claimed that there are no therapies specifically approved for this condition currently.

The drug maker said most patients with cGVHD were prescribed glucocorticoids, a systemic steroid treatment, which could act upon cells throughout the entire body. However, research indicated that long-term use of steroids could lead to serious health complications..

According to Head of Oncology at Pharmacyclics, Danelle James, "This fourth Breakthrough Therapy Designation from the FDA shows the promise of IMBRUVICA and its unique mechanism of action as a potential therapy beyond blood cancers, including chronic graft-versus-host-disease, a severe inflammatory condition with currently no approved therapies specifically for these patients."

He added, "We are committed to continuing to evaluate the potential benefit ibrutinib may offer in treating blood cancers, solid tumors and other health conditions with unmet medical needs."

Posted In: BiotechNewsFDAGeneral
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