Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



Will the FDA Clear Cardiome?

Never known for its brevity, the FDA's cardio-renal division released a nearly 300-page briefing document (PDF file) ahead of an advisory panel meeting regarding Cardiome's (Nasdaq: CRME  ) lead drug. The hearing, scheduled for Tuesday, will weigh the approval of Vernakalant, a treatment for abnormal heart rhythms.

Cardiome and marketing partner Astellas Pharma first filed a New Drug Application for Vernakalant in March 2006, after two successful phase 3 trials, but the application was not accepted because of "deficiencies" in the filing. Cardiome eventually corrected these issues, and it now has a PDUFA action date of Jan. 19, 2008.

Investors wanting only to read the shortcut version of the briefing document and get an overview of the FDA's thoughts (a luxury I didn't have) can skip to page 265, where they'll find the secondary reviewer's opinion of all the other individual opinions in the previous sections.

Numerous FDA reviewers in the briefing document were positive on the drug's efficacy and safety, and raised only minor concerns about Vernakalant. For instance, the pharmacometrics staff found that "the NDA is acceptable," and the statistical reviewers found significant evidence of the drug's efficacy in controlling atrial fibrillation. The secondary reviewer described the Vernakalant data as a "persuasive demonstration of efficacy."

The mere fact that the FDA had to call an advisory committee meeting for opinions on Vernakalant suggests that its NDA is not a shoo-in for approval. (Or rejection, for that matter.) From 2002 to 2004, for example, only 31% of drugs subject to an advisory panel hearing were approved on the first go-round.

Nonetheless, numerous separate FDA reviewers in the briefing document wrote positively on the drug's efficacy and safety, raising only minor concerns about the drug. Unlike Genentech (NYSE: DNA  ) last week, the odds are extremely high that Vernakalant will get a positive recommendation from the advisory panel.

Thus, the advisory panel will more likely help to delineate Vernakalant's labeling, and determine how broadly the drug will be used in different patient groups. When the drug's PDUFA date rolls around on Jan. 19, investors can thus expect approval, or at worst, a short delay to finalize labeling.

More Foolishness on Cardiome:

Read/Post Comments (0) | Recommend This Article (3)

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.

Compare Brokers

Fool Disclosure

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: 549930, ~/Articles/ArticleHandler.aspx, 10/22/2016 8:03:20 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...

Today's Market

updated 22 hours ago Sponsored by:
DOW 18,145.71 -16.64 -0.09%
S&P 500 2,141.16 -0.18 -0.01%
NASD 5,257.40 15.57 0.30%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

3/26/2009 4:00 PM
DNA $94.97 Down +0.00 +0.00%
Genentech CAPS Rating: ****