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AbbVie's (ABBV) Humira Drug Label Update Approved by FDA
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AbbVie Inc.’s (ABBV - Free Report) announced that the FDA has approved the inclusion of moderate to severe fingernail psoriasis data on the label of AbbVie’s multi-utility TNF blocker drug, Humira. With this approval, Humira becomes the first and the only drug to include data on fingernail psoriasis in its prescribing information.
The data have been added to the "Clinical Studies" sections of the Prescribing Information of the Humira label as a third psoriasis study (Study Ps-III) in the plaque psoriasis. With the FDA approval, healthcare providers are likely to be able to make informed medical decisions, while prescribing treatments for psoriasis patients.
AbbVie’s share price has increased 14% in the past one year, outperforming the Zacks classified Large-Cap Pharmaceuticals industry’s gain of 5.8%.
The consent by the FDA was based on the data from a multicenter, double-blind phase III study conducted to evaluate fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis. Moreover, data from the 26-week study indicated that 48.9% of patients treated with Humira achieved a Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal). It also showed a two grade improvement from the baseline after 26 weeks. On the contrary, 6.9% of patients treated with a placebo achieved clear or minimal assessment.
We note that Humira was already approved in the U.S. for the treatment of adults with moderate to severe chronic plaque psoriasis in 2008. Additionally, this drug is accepted for several indications like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, ulcerative colitis and juvenile idiopathic arthritis. With several companies striving to bring Humira biosimilars to the market, AbbVie has been focusing on diversifying its revenue base and lowering its dependence on the product. Further, the company is working on expanding Humira’s label in the fields of rheumatology, gastroenterology (pediatric ulcerative colitis), and dermatology (pediatric psoriasis).
In fact, Humira is considered to be the key growth driver at AbbVie. In the year 2016, Humira generated total sales of approximately $16 billion, up 14.7% year over year. It contributed almost 63% to the company’s total sales during same period.
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , Roche Holding AG (RHHBY - Free Report) and Grifols, S.A. (GRFS - Free Report) . While Grifols sports a Zacks Rank #1 (Strong Buy), Roche and Vertex carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vertex’s earnings estimates for 2017 were stable over the past 30 days. Also, the company’s share price rose 45.6% since the beginning of this year.
Roche’s earnings estimates increased from $1.70 to $1.90 for 2017, over the last 30 days. Also, the company’s share price rose 13% since the beginning of this year.
Grifols’ earnings estimates increased from $1.04 to $1.14 for 2017, over the last 30 days. Further, the company’s share price increased 18.3% since the beginning of this year.
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AbbVie's (ABBV) Humira Drug Label Update Approved by FDA
AbbVie Inc.’s (ABBV - Free Report) announced that the FDA has approved the inclusion of moderate to severe fingernail psoriasis data on the label of AbbVie’s multi-utility TNF blocker drug, Humira. With this approval, Humira becomes the first and the only drug to include data on fingernail psoriasis in its prescribing information.
The data have been added to the "Clinical Studies" sections of the Prescribing Information of the Humira label as a third psoriasis study (Study Ps-III) in the plaque psoriasis. With the FDA approval, healthcare providers are likely to be able to make informed medical decisions, while prescribing treatments for psoriasis patients.
AbbVie’s share price has increased 14% in the past one year, outperforming the Zacks classified Large-Cap Pharmaceuticals industry’s gain of 5.8%.
The consent by the FDA was based on the data from a multicenter, double-blind phase III study conducted to evaluate fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis. Moreover, data from the 26-week study indicated that 48.9% of patients treated with Humira achieved a Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal). It also showed a two grade improvement from the baseline after 26 weeks. On the contrary, 6.9% of patients treated with a placebo achieved clear or minimal assessment.
We note that Humira was already approved in the U.S. for the treatment of adults with moderate to severe chronic plaque psoriasis in 2008. Additionally, this drug is accepted for several indications like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, ulcerative colitis and juvenile idiopathic arthritis. With several companies striving to bring Humira biosimilars to the market, AbbVie has been focusing on diversifying its revenue base and lowering its dependence on the product. Further, the company is working on expanding Humira’s label in the fields of rheumatology, gastroenterology (pediatric ulcerative colitis), and dermatology (pediatric psoriasis).
In fact, Humira is considered to be the key growth driver at AbbVie. In the year 2016, Humira generated total sales of approximately $16 billion, up 14.7% year over year. It contributed almost 63% to the company’s total sales during same period.
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , Roche Holding AG (RHHBY - Free Report) and Grifols, S.A. (GRFS - Free Report) . While Grifols sports a Zacks Rank #1 (Strong Buy), Roche and Vertex carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vertex’s earnings estimates for 2017 were stable over the past 30 days. Also, the company’s share price rose 45.6% since the beginning of this year.
Roche’s earnings estimates increased from $1.70 to $1.90 for 2017, over the last 30 days. Also, the company’s share price rose 13% since the beginning of this year.
Grifols’ earnings estimates increased from $1.04 to $1.14 for 2017, over the last 30 days. Further, the company’s share price increased 18.3% since the beginning of this year.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>