FDA Gives Treats to a Few Drugmakers

After this month's string of rejections, I was beginning to think that the Food and Drug Administration had lost its APPROVED stamp somewhere in its junk drawer. 

But the agency was just waiting for the right moment. The FDA gave two thumbs-ups yesterday.

The first wasn't so much an approval as an expanded use. Bristol-Myers Squibb's (NYSE: BMY  ) Sprycel was already approved for treating chronic myeloid leukemia after patients failed Novartis' Gleevec. Now, the FDA says the drug can be used as a first-line treatment. The expanded approval will increase the potential patient population, but it also has competition on the way. Novartis' Tasigna also beat Gleevec in a recent head-to-head trial, and has been approved as a first-line treatment as well.

The second drug getting an FDA green light was Sunovion Pharmaceuticals' Latuda. Sunovion is owned by Dainippon Sumitomo Pharma, which you can find on the Tokyo Stock Exchange, but I'm not sure Latuda should be the trigger that makes you want to investigate further.

The drug enters the crowded -- dare I say crazy -- schizophrenia market. With AstraZeneca's Seroquel, Pfizer's (NYSE: PFE  ) Geodon, and Eli Lilly's (NYSE: LLY  ) Zyprexa, not to mention generic versions of Johnson & Johnson's (NYSE: JNJ  ) Risperdal, I have a hard time seeing the drug gaining much traction.

Where does the pair of approvals leave Forest Labs (NYSE: FRX  ) , Biodel (Nasdaq: BIOD  ) , and Avanir Pharmaceuticals (Nasdaq: AVNR  ) , which could all hear from the FDA today? In about the same place they were before.

While we can draw some conclusions from the FDA's actions -- the agency seems to be getting more safety-conscious -- drug approvals ultimately boil down to the data on the individual drugs. Forest's ceftaroline looks like a shoo-in, assuming there are no manufacturing issues. Approvals for Biodel's Linjeta and Avanir's AVP-923 look a little iffier, given a weak data package and a history of heart issues, respectively.

A previous version of this article incorrectly stated that Tasigna had not yet been approved as a first-line treatment. The Fool regrets the error.

Keep up with the drugs facing FDA decisions using The Fool's My Watchlist feature, or subscribe to Brian Orelli's RSS feed here.

Pfizer is a Motley Fool Inside Value recommendation. Novartis is a Motley Fool Global Gains pick. Motley Fool Options has recommended a diagonal call position on Johnson & Johnson, which is a Motley Fool Income Investor pick. The Fool owns shares of Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.


Read/Post Comments (0) | Recommend This Article (5)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 1350886, ~/Articles/ArticleHandler.aspx, 11/26/2014 12:56:03 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement