Human Genome: FDA Panel Live Blog
WASHINGTON, D.C. (
Human Genome Sciences
(HGSI) brings its experimental lupus drug Benlysta in front of a U.S. Food and Drug Administration advisory panel today, a pivotal step in the company's efforts to market the first new lupus drug in about 50 years.
If approved, Benlysta is expected to be the first blockbuster drug to emerge from Human Genome's research labs, possibly generating peak sales greater than $2 billion. GlaxoSmithKline (GSK) will co-market Benlysta under a partnership agreement with Human Genome.
The FDA is asking its advisory panel Tuesday to consider the benefits and risks of Benlysta in patients with the autoimmune disease lupus. Human Genome Sciences conducted two, large phase III studies demonstrating greater overall patient response to treatment with Benlysta compared to placebo.
In a review of Benlysta posted Friday, FDA reviewers questioned the robustness of Benlysta's benefit and raised some safety concerns, including a potential higher suicide risk associated with the drug."Clearly there is a need for effective therapies in SLE
>To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- 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 + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV