Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nyse  >  Abbott Laboratories    ABT

Mes dernières consult.
Most popular
News SummaryMost relevantAll newsofficial PublicationsSector newsTweets

FDA Backs Approval of Abbott's Humira for New Use

share with twitter share with LinkedIn share with facebook
share via e-mail
08/28/2012 | 10:06pm CEST

WASHINGTON--A federal advisory panel backed the use of an Abbott Laboratories (>> Abbott Laboratories) drug, Humira, as a treatment for patients with inflammatory bowel disease, saying many patients would benefit from treatment with the product.

Abbott is seeking expanded approval from the U.S. Food and Drug Administration for its anti-inflammatory drug Humira to treat ulcerative colitis. Humira, which had almost $8 billion in annual sales last year, currently is approved to treat rheumatoid arthritis, Crohn's Disease and other inflammatory conditions.

The drug was reviewed Tuesday by the FDA's gastrointestinal drugs advisory committee, which is made up of non-FDA medical experts. The panel voted 15 to 2 on a question that asked whether "the expected benefits outweigh the known and potential risks of Humira" for the treatment of certain patients with ulcerative colitis.

The vote amounts to a recommendation that the FDA approve the product. The FDA usually follows the advice of its panels but is not required to. The FDA declined to approve Humira for colitis last year and asked the company for additional information. The agency also said it would seek the advice of an advisory panel.

Abbott studied Humira in two clinical trials involving more than 1,000 patients. Both studies met goals showing Humira improved rates of disease remission compared to a placebo in people with colitis, an inflammatory bowel disease that causes pain, diarrhea and other symptoms. Patients in the studies also were being treated with older commonly used drugs for colitis including steroids.

Although the FDA agreed that the studies met their goals, the agency questioned whether the difference in remission rates of less than 10% between the Humira groups and placebo groups was "clinically meaningful." The studies showed about 17% to 19% of patients being treated with Humira achieved disease remission at eight weeks compared to about 9% of patients being treated with a placebo, according to the FDA. After one year of treatment the results were similar.

"The central issue is whether the applicant has adequately demonstrated and provided evidence of benefit sufficient to conclude that the benefit outweighs the risks of Humira for [ulcerative colitis]," the FDA said in a background memo prepared for the advisory committee meeting.

However, the majority of the panel disagreed, voting 15 to 1 saying that the differences between the drug and placebo groups were clinically meaningful.

Abbott officials and doctors who spoke on behalf of the company during the panel meeting said many patients with colitis don't respond well to currently available treatments, which also include Johnson & Johnson's (>> Johnson & Johnson) Remicade, and need an additional option. The company proposed stopping treatment in patients who don't respond to the drug after eight weeks of treatment.

Write to Jennifer Corbett Dooren at [email protected]

(CORRECTION: This item was corrected to show that the vote tally was 15 to 2. The original incorrectly stated 12 to 2 in the third paragraph.)

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

Stocks mentioned in the article : Abbott Laboratories, Johnson & Johnson
Stocks mentioned in the article
ChangeLast1st jan.
ABBOTT LABORATORIES -1.15% 59.19 Delayed Quote.4.92%
JOHNSON & JOHNSON -0.70% 126.66 Delayed Quote.-8.71%
share with twitter share with LinkedIn share with facebook
share via e-mail
04/20ABBOTT : Extends Title Sponsorship of Abbott : World Marathon Majors through 202..
04/20ABBOTT LABORATORIES : Sens. Durbin, Duckworth Issue Statement on Nominations of ..
04/20ABBOTT LABORATORIES : New ensure max protein helps americans go for their health..
04/19ABBOTT LABORATORIES : An Application for the Trademark "VITAL" Has Been Filed by..
04/19ABBOTT LABORATORIES : Shares Topple After Pharma Unit Struggles In First Quarter
04/19ABBOTT LABORATORIES : Sen. Richard J. Durbin (D-IL) News Release
04/19ABBOTT LABORATORIES : Heart devices help Abbott Labs beat earnings estimates
04/18ABBOTT LABORATORIES : Heart monitors help Abbott Labs beat earnings estimates
04/18ABBOTT LABORATORIES : sticks to earlier forecasts, disappoints investors
04/18ABBOTT LABORATORIES (NYSE : ABT) Files An 8-K Results of Operations and Financia..
More news
News from SeekingAlpha
08:38aTHE PASSIVE DGI CORE PORTFOLIO : Income, Safety, And Growth 
04/20Danaher's Growing Leverage To Life Sciences Improves The Long-Term Outlook 
04/19Abbott Laboratories 2018 Q1 - Results - Earnings Call Slides 
04/18Abbott Laboratories' (ABT) CEO Miles White on Q1 2018 Results - Earnings Call.. 
04/18Abbott Q1 top line up 
Financials ($)
Sales 2018 31 081 M
EBIT 2018 6 458 M
Net income 2018 2 536 M
Debt 2018 15 831 M
Yield 2018 1,89%
P/E ratio 2018 45,42
P/E ratio 2019 32,23
EV / Sales 2018 3,83x
EV / Sales 2019 3,52x
Capitalization 103 B
Duration : Period :
Abbott Laboratories Technical Analysis Chart | ABT | US0028241000 | 4-Traders
Technical analysis trends ABBOTT LABORATORIES
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 19
Average target price 68,6 $
Spread / Average Target 16%
EPS Revisions
Miles D. White Chairman & Chief Executive Officer
Brian B. Yoor Chief Financial Officer & Executive VP-Finance
Roxanne Schuh Austin Independent Director
Samuel C. Scott Independent Director
Glenn Fletcher Tilton Independent Director
Sector and Competitors
1st jan.Capitalization (M$)
JOHNSON & JOHNSON-8.71%339 783
PFIZER0.86%217 897
NOVARTIS-7.67%204 972
ROCHE HOLDING LTD.-12.52%191 890