AbbVie Inc. ABBV announced that it has initiated a phase III program on ABT-494 for the treatment of patients with rheumatoid arthritis (RA).
The program includes five phase III studies that will evaluate ABT-494 in adult patients with inadequate responses to conventional or biologic disease-modifying antirheumatic drugs (DMARDs), as well as methotrexate-naïve patients.
Currently, patient enrollment in the first two phase III studies has been initiated. The first study, SELECT-COMPARE, will evaluate ABT-494 in combination with methotrexate (MTX) in adults (n=1,500) with moderate-to-severely active RA who had an inadequate response to prior treatment with MTX. The study will include Humira as an active comparator.
The second study, SELECT-NEXT, will evaluate two doses of ABT-494 (once-daily use of 15 mg and 30 mg) in combination with conventional synthetic DMARDS on patients (n=600) who had an inadequate response or intolerance to conventional synthetic DMARDs.
The company also said that in early 2016, it will initiate the other three phase III studies, that will evaluate ABT-494 in patients with an inadequate response to biologics and patients who are MTX-naïve.
We remind investors that the RA market is highly crowded with drugs like Orencia, Kineret, Cimzia and Enbrel among others.
We note that AbbVie already has a strong presence in this market with its blockbuster drug, Humira. Apart from RA, Humira is approved in the U.S. for several indications like moderately-to-severely active polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderate-to-severe Crohn’s disease, moderate-to-severe ulcerative colitis, ankylosing spondyloarthritis, pediatric Crohn’s disease, and moderate-to-severe chronic plaque psoriasis. Humira recorded worldwide sales of $10.3 billion in the first nine months of 2015.
Meanwhile, ABT-494 is also being evaluated in a phase II study for the treatment of patients with Crohn's disease.
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Horizon Pharma plc HZNP, Anika Therapeutics Inc. ANIK and Ligand Pharmaceuticals Incorporated LGND, each sporting a Zacks Rank #1 (Strong Buy).
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