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AbbVie's (ABBV) Humira Wins CHMP Backing for Expanded Use
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AbbVie Inc. (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive recommendation for the label expansion of its lead prescription drug, Humira for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) in adolescents aged 12 years and above.
In Jul last year, Humira was granted marketing approval for the same indication in adults by the European Commission. Upon approval for the latest filing, Humira will become the first and only biologic treatment option for patients aged 12 years and above.
Humira is an anti-inflammatory product currently approved for several other indications such as the reduction of signs and symptoms of psoriatic arthritis, ankylosing spondylitis, moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, Crohn’s disease (CD), ulcerative colitis and chronic plaque psoriasis arthritis in the U.S. It is also approved for the treatment of moderate-to-severe CD in children aged 6 years and above. The drug has been approved in more than 90 countries across 14 globally approved indications and is currently used in the treatment of more than a million patients worldwide.
Moreover, Humira enjoys orphan drug status for the treatment of moderate-to-severe HS (Hurley stage II and Hurley stage III disease), which makes the product eligible for seven years of market exclusivity in this indication.
Per the company’s press release, 298 adolescents, representing around 0.09% of a total 328,634 adolescents sampled, aged between 12 and 17 years, have been diagnosed with HS. Hence, an approval of Humira in this indication would give the company access to a huge population of patients.
We note that Humira is the key growth driver at AbbVie. The drug garnered sales of $4 million in the third quarter of 2016, representing more than 66% of the company’s total revenue.
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Cambrex Corp. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has increased 19.4% year to date.
Cambrex’s earnings estimates have increased from $2.46 to $2.55 for 2016 and have increased from $2.91 to $3.06 for 2017 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 10.9% year to date.
Vanda’s loss estimates have narrowed from 68 cents per share to 56 cents per share for 2016 while its earnings estimates have increased from 16 cents per share to 17 cents per share for 2017 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price surged 77.8% year to date.
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AbbVie's (ABBV) Humira Wins CHMP Backing for Expanded Use
AbbVie Inc. (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive recommendation for the label expansion of its lead prescription drug, Humira for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) in adolescents aged 12 years and above.
In Jul last year, Humira was granted marketing approval for the same indication in adults by the European Commission. Upon approval for the latest filing, Humira will become the first and only biologic treatment option for patients aged 12 years and above.
Humira is an anti-inflammatory product currently approved for several other indications such as the reduction of signs and symptoms of psoriatic arthritis, ankylosing spondylitis, moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, Crohn’s disease (CD), ulcerative colitis and chronic plaque psoriasis arthritis in the U.S. It is also approved for the treatment of moderate-to-severe CD in children aged 6 years and above. The drug has been approved in more than 90 countries across 14 globally approved indications and is currently used in the treatment of more than a million patients worldwide.
Moreover, Humira enjoys orphan drug status for the treatment of moderate-to-severe HS (Hurley stage II and Hurley stage III disease), which makes the product eligible for seven years of market exclusivity in this indication.
Per the company’s press release, 298 adolescents, representing around 0.09% of a total 328,634 adolescents sampled, aged between 12 and 17 years, have been diagnosed with HS. Hence, an approval of Humira in this indication would give the company access to a huge population of patients.
We note that Humira is the key growth driver at AbbVie. The drug garnered sales of $4 million in the third quarter of 2016, representing more than 66% of the company’s total revenue.
ABBVIE INC Price
ABBVIE INC Price | ABBVIE INC Quote
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Cambrex Corp. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has increased 19.4% year to date.
Cambrex’s earnings estimates have increased from $2.46 to $2.55 for 2016 and have increased from $2.91 to $3.06 for 2017 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 10.9% year to date.
Vanda’s loss estimates have narrowed from 68 cents per share to 56 cents per share for 2016 while its earnings estimates have increased from 16 cents per share to 17 cents per share for 2017 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price surged 77.8% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>