Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Nyse  >  Johnson & Johnson    JNJ

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

Johnson & Johnson : FDA Grants Priority Review to J&J's Bedaquiline Tuberculosis Treatment

share with twitter share with LinkedIn share with facebook
share via e-mail
0
12/31/2012 | 04:02pm CEST
   By Nathalie Tadena 
 

The Food and Drug Administration has granted accelerated approval for Johnson & Johnson's (JNJ) drug to treat a drug-resistant form of tuberculosis.

The drug, bedaquiline, has faced concerns about an imbalance of deaths seen in clinical studies. J&J's Janssen Research & Development had asked the FDA for accelerated approval of bedaquiline, which is a type of temporary approval based on less clinical data than required for traditional drug approvals.

The accelerated approval was based on data from a pair of Phase 2 studies--one of which showed 77.6% of patients in the treatment group reaching treatment success after 24 weeks compared with 57.6% of those in the placebo group--but the prescribing information for the treatment will include boxed warnings regarding increased risk of death.

Last month, an FDA panel supported a type of early approval for J&J's experimental drug; however, panel members were divided on whether bedaquiline played a role in deaths seen in clinical studies. While the FDA has said the safety data currently available for bedaquiline suggest the product appears safe, there is a potential for the highest dose of the product to cause a small change in the heart's rhythm. The FDA had said there wasn't enough data to rule out potential drug side effects on the liver and the heart. There were more deaths seen among patients being treated with bedaquiline although most of the deaths were attributed to the underlying disease.

The consumer group Public Citizen has strongly opposed the accelerated approval of bedaquiline because clinical trials showed the drug could be highly dangerous.

Only about 100 cases of drug-resistant TB are seen each year in the U.S. but the problem is more severe in typically poor countries outside the U.S.

Tuberculosis is a bacterial infection that mostly involves the lungs. It is treated with a combination of four drugs for at least six months, according to the National Heart, Lung and Blood Institute. Bedaquiline is designed to work in a new way to treat TB and would be used with other drugs.

However, there is evidence that some forms of TB can't be treated with currently available drugs, which the FDA has said "threatens to erode the progress made in the worldwide control of tuberculosis."

Tuberculosis can be fatal if it's not properly treated.

Write to Nathalie Tadena at nathalie.tadena@dowjones.com

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

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on JOHNSON & JOHNSON
03/25 AT&T, Verizon halt Google ads over extremist videos
03/24 JOHNSON & JOHNSON : Innovation launches Singapore QuickFire Challenge Competitio..
03/24 AT&T and Johnson & Johnson Pull Ads From YouTube
03/24 OPPORTUNISM KNOCKS : Marketers and media take on Google
03/24 JOHNSON & JOHNSON : EPREX Marketing Authorisation Extended to Include Treatment ..
03/24 YouTube's bid to grab TV dollars imperiled by advertiser revolt
03/24 HOLOGIC : Global in-Vitro Diagnostics (IVD) Market-Danaher, Hologic, Alere, BD, ..
03/24 JOHNSON & JOHNSON : Global First Aid Kit Market-Honeywell, Wah Lee, Yunnan Baiya..
03/23 JOHNSON & JOHNSON : Investigators at Johnson & Johnson Report New Data on Schizo..
03/23 JOHNSON & JOHNSON : Thicon announces completion of acquisition of torax medical,..
More news
Sector news : Pharmaceuticals - NEC
03/24 NOVO NORDISK A/S : EMA panel backs Novo Nordisk's haemophilia B drug
03/23DJPRESS RELEASE : FDA Grants Approval for -3-
03/23DJPRESS RELEASE : FDA Grants Approval for -2-
03/23DJPRESS RELEASE : FDA Grants Approval for BAVENCIO(R) (avelumab), the First Immuno..
03/23 TEVA PHARMACEUTICAL INDUSTRIES : Pharm says media reports of up to 6,000 layoffs..
More sector news : Pharmaceuticals - NEC
News from SeekingAlpha
03/24 The View From The Top
03/24 RETIREES : How To Protect The Principal Of Your Dividend Portfolio
03/24 European advisory committee backs J & J's Elmiron for bladder pain syndrome
03/24 WALL STREET BREAKFAST : Art Of The Healthcare Deal
03/24 YouTube ad exodus continues
Advertisement
Financials ($)
Sales 2017 74 632 M
EBIT 2017 23 011 M
Net income 2017 17 928 M
Finance 2017 21 362 M
Yield 2017 2,67%
P/E ratio 2017 19,01
P/E ratio 2018 17,74
EV / Sales 2017 4,27x
EV / Sales 2018 4,01x
Capitalization 340 163 M
More Financials
Chart JOHNSON & JOHNSON
Duration : Period :
Johnson & Johnson Technical Analysis Chart | JNJ | US4781601046 | 4-Traders
Full-screen chart
Technical analysis trends JOHNSON & JOHNSON
Short TermMid-TermLong Term
TrendsBullishBullishBullish
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 21
Average target price 126 $
Spread / Average Target 0,65%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Alex Gorsky Chairman & Chief Executive Officer
Dominic J. Caruso Chief Financial Officer & Vice President
Paulus Stoffels Chief Scientific Officer & Executive VP
Charles O. Prince Independent Director
William David Perez Independent Director
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
JOHNSON & JOHNSON8.91%340 163
ROCHE HOLDING LTD.8.60%219 545
PFIZER INC.4.68%202 474
NOVARTIS AG-0.94%195 096
MERCK & CO., INC.7.32%173 465
SANOFI7.76%115 582
More Results