AbbVie Inc. (ABBV) announced that Humira met the primary endpoint in a pivotal phase III study conducted in patients suffering from moderate-to-severe hidradenitis suppurativa (HS). The company’s shares were up 1.2% on the news.
AbbVie presented data from the first of two pivotal phase III studies. The 36-week, multicenter, randomized, double-blind, two-period PIONEER I (n= 507) study was conducted to evaluate the safety and efficacy of Humira compared to placebo. Results showed that Humira 40 mg demonstrated a significant improvement in HS-related abscesses and inflammatory nodules at 12 weeks compared to placebo (41.8% versus 26%).
These results were presented at the Annual European Society for Dermatological Research (ESDR) Meeting. Meanwhile, the company intends to present data from the second phase III study (PIONEER II) at a forthcoming medical congress.
We note that Humira is the key growth driver at AbbVie. The product generated revenues of $5.9 billion in the first half of 2014.
Humira is already approved for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, ulcerative colitis and juvenile idiopathic arthritis, among others.
Meanwhile, AbbVie is working on expanding Humira’s label further into indications like fingernail psoriasis in patients with moderate-to-severe chronic plaque psoriasis.
We are pleased with the encouraging results from the study. Once approved, the new medication will provide significant benefit to patients suffering from HS considering the lack of approved treatments. According to the press release issued by AbbVie, HS affects nearly 1% of the general adult population across the world.
AbbVie is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Allergan Inc. (AGN), Akorn, Inc. (AKRX) and Abbott Laboratories (ABT). While Allergan and Akorn are Zacks Rank #1 (Strong Buy) stocks, Abbott Laboratories holds a Zacks Rank #2 (Buy).
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