Biotech 101: Breakthrough Therapy

The breakthrough therapy designation is a relatively new term, but it's one biotech investors should make sure they're familiar with. The designation gives drugmakers more access to the Food and Drug Administration to speed approval of drugs that look promising.

In theory, at least.

We haven't seen enough drugs with the designation get approved to know if the breakthrough therapy designation is actually speeding approvals. There have been isolated incidences of early approvals like Novartis' (NYSE: NVS  ) Zykadia, which was approved to treat lung cancer four months before the FDA was scheduled to make a decision.

But we saw early approvals occasionally happening before the breakthrough designation was implemented. Medivation's (NASDAQ: MDVN  ) Xtandi, for instance, was approved just three months after submitting its application for the cancer drug.

And then we have companies such as Sarepta Therapeutics (NASDAQ: SRPT  ) , which has told investors that it doesn't think it needs to bother applying for breakthrough therapy designation for its muscular dystrophy drug because it's having plenty of interaction with the FDA.

Watch the following video for more thoughts on breakthrough therapy designation from the Fool's senior biotech specialist, Brian Orelli, and health-care analyst David Williamson.

The newest breakthrough in Silicon Valley
If you thought the iPod, the iPhone, and the iPad were amazing, just wait until you see this. One hundred of Apple's top engineers are busy building one in a secret lab. And an ABI Research report predicts 485 million of them could be sold over the next decade. But you can invest in it right now, for just a fraction of the price of Apple stock. Click here to get the full story in this eye-opening new report.


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

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: 2963897, ~/Articles/ArticleHandler.aspx, 12/22/2014 4:33:30 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