Back to top
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Bristol Myers Squibb Company (BMY) - $25 value - yours FREE >>
Johnson & Johnson (JNJ) - $25 value - yours FREE >>
We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol Myers Squibb Company (BMY) - $25 value - yours FREE >>
Johnson & Johnson (JNJ) - $25 value - yours FREE >>
Image: Bigstock
AbbVie, J&J's Imbruvica Gets Breakthrough Therapy Status
AbbVie Inc. (ABBV - Free Report) and Johnson & Johnson’s (JNJ - Free Report) 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 - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) – both are Zacks Rank #1 (Strong Buy) stocks. Johnson & Johnson carries a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>