AbbVie Inc. ABBV and Johnson & Johnson’s JNJ Imbruvica got a fourth Breakthrough Therapy Designation (BTD), this time for a non-cancer indication. The FDA granted BTD to Imbruvica for the treatment of chronic graft-versus-host-disease (cGVHD) after one or more lines of systemic therapy have failed. Imbruvica was also granted Orphan Drug Designation (ODD) for the indication.
Breakthrough Therapy Designation helps fasten the development and review of drugs which are being evaluated for the treatment of serious conditions and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments on clinically significant endpoint(s).
Currently, no treatments are available specifically for cGVHD with most patients being prescribed glucocorticoids, a systemic steroid treatment. However, according to the Fred Hutchinson Cancer Research Center, research shows that serious health complications can arise from the long-term use of steroids.
Earlier BTDs for Oncology Indications
Imbruvica has previously received BTD for oncology indications including for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), the treatment of Waldenström's macroglobulinemia (WM) and the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with a deletion of the short arm of chromosome 17 (del 17p).
Pipeline in a Molecule
Imbruvica became a part of AbbVie’s portfolio following its acquisition of Pharmacyclics. Currently approved for certain types of blood cancer, Imbruvica has multi-billion dollar potential and AbbVie is exploring the potential to expand Imbruvica’s label into solid tumors and autoimmune diseases. AbbVie is positioning Imbruvica as a “pipeline in a molecule” – the treatment is in several studies including 14 phase III studies.
AbbVie is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the healthcare sector include Pfizer Inc. PFE and Bristol-Myers Squibb Company BMY – both are Zacks Rank #1 (Strong Buy) stocks. Johnson & Johnson carries a Zacks Rank #2 (Buy).
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