Arena Pharma: FDA Panel Live Blog
Arena is trying to do what competitor Vivus failed to achieve in July -- convince a group of outside experts that the company has a weight-loss drug that is both effective and safe for the millions of obese Americans who can't seem to shed the pounds with diet and exercise alone.
In a review posted to the FDA's web site Tuesday, the agency's reviewers said lorcaserin provided only marginal weight loss for patients. The FDA also raised questions about the drug's safety and raised a concern about a potential cancer risk in animals.The FDA's tough review spooked investors, sending Arena shares plunging. The stock closed Wednesday at $3.74, down 45% over the past two days. Arena's stock will be halted today for the duration of the FDA advisory panel. It's important to note that FDA drug reviews released ahead of advisory panel meetings are often sharply critical and sometimes do not accurately predict the ultimate vote of the panel's outside experts. Arena's enters the fray of an FDA advisory panel amidst a regulatory environment obsessed with drug safety and (so far) unkind to obesity drugs. On Wednesday, eight experts siting on the same FDA advisory panel voted to withdraw Abbott Labs' (ABT) weight-loss drug Meridia from the market, while another six panelists voted to restrict the drug's distribution. In July, a similar panel voted overwhelmingly against Vivus' drug Qnexa. Arena will try to fight against this tide of skepticism over weight-loss drugs by citing lorcaserin's lack of serious side effects and two years of safety data showing patients are free from any additional cardiovascular safety problems. The company believes there is strong evidence to compel both the FDA and its advisory panel to support lorcaserin's approval. Next up, an FDA advisory panel will review Orexigen Therapeutics' (GSK) obesity drug Contrave in December. --Written by Adam Feuerstein in Boston.
>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
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $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
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV