This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

PREZISTA(R)(darunavir) Oral Suspension Receives European Commission Approval For Young Children With HIV-1 Infection

BEERSE, Belgium, October 25, 2012 /PRNewswire/ --

Janssen-Cilag International announced today that the European Commission (EC) has approved a 100mg/ml oral suspension of PREZISTA® (darunavir), and the use of darunavir co-administered with low dose ritonavir, for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART)-experienced paediatric patients age 3 years and above, weighing at least 15 kg body weight. It must be taken in combination with other ARTs.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/56605-janssen-prezista-oral-suspension

The approval is based on a 48-week analysis of ARIEL, a Phase II, open-label trial to evaluate pharmacokinetics, safety, tolerability and antiviral activity of darunavir in combination with low dose ritonavir in treatment-experienced HIV-1 infected children from 3 to < 6 years of age. [ 1 ]

"This approval is exciting news for young children with HIV, as there is a significant and often overlooked need in the availability of specifically formulated antiretroviral therapies for this patient population. An oral suspension that makes it easier for children with HIV to take their treatment as prescribed is very important for this group, who must maintain a lifetime of daily therapy to prevent the progression of HIV to AIDS," said Dr Avy Volari, MD, Chris Hani Baragwanath Hospital, Johannesburg, South Africa and lead author of the ARIEL Study.

Long-term durability of treatment is an important issue for young children living with HIV, which can be affected by challenges in adherence to therapy.  Strict adherence to treatment regimens and dosing schedules is crucial to prevent virological failure and the development of drug resistance.  Currently, one in eight children and adolescents with HIV in Europe experience virological failure of three drug classes within five years, which can severely limit treatment options into adolescence and adulthood. [ 2 ]

The EC also recommended approval of the darunavir 100 mg/ml oral suspension for use in patients who are unable to swallow tablets, providing an additional way to receive treatment.

1 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,912.11 -70.48 -0.42%
S&P 500 1,969.95 -8.96 -0.45%
NASDAQ 4,442.6980 -2.2110 -0.05%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs