CV Therapeutics Tries to Cast a Wider Net

On Monday, Rule Breakers pick CV Therapeutics (Nasdaq: CVTX  ) took another step to widen the use of its only marketed drug, Ranexa, with the Food and Drug Administration accepting multiple marketing applications for the drug.

Ranexa is CV Therapeutics' lead drug. In January, the FDA approved it to help reduce angina in those who suffer from attacks of the excruciating chest pains.

The problem with Ranexa is that it's only approved for angina sufferers not adequately treated by their current medications, like beta blockers. Ranexa has this second-line label because of a perceived elevated risk of a heart condition that can result in sudden death when it is used.

CV Therapeutics posted $18.4 million in Ranexa sales for the third quarter, up 20% versus the previous quarter. With the current Ranexa label likely impeding effective marketing of the drug, CV Therapeutics ran a large phase 3 study named Merlin to try to convince the FDA to allow a broader label for the drug as a front-line treatment for angina.

The supplemental New Drug Application that the FDA accepted Monday is CV Therapeutics' attempt to get this improved front-line angina label after the Merlin study was completed earlier this year.

In a secondary endpoint of the study, CV Therapeutics also measured Ranexa's effects on improving diabetics' blood glucose levels. Controlling blood glucose levels with insulin shots like Sanofi-Aventis' (NYSE: SNY  ) Lantus or other anti-diabetic compounds like Eli Lilly (NYSE: LLY  ) and Amylin Pharmaceuticals' (Nasdaq: AMLN  ) Byetta is an important part of any type 2 diabetics' daily routine.

Based on strong Merlin diabetes data, CV Therapeutics filed to try to get Ranexa approved as a treatment for diabetics with coronary artery disease. This is a very large patient population.

Besides its effectiveness, what makes Ranexa stand out compared with competitors like GlaxoSmithKline's (NYSE: GSK  ) Avandia is that it might not have the potential heart safety issues that Avandia does. Considering that most diabetics die of coronary heart disease, that could be a potent marketing advantage.

The PDUFA date for both the Ranexa front-line angina label expansion and new diabetes indication is July 28 of next year. Because the applications are under review by different FDA divisions, it's likely that approval or denial will come at different times despite the same PDUFA action date.

It's worth noting that the FDA's decision on each application has no bearing on the other's odds of approval. The diabetes indication might be a stretch without further clinical testing, but now CV Therapeutics has two shots to help jump-start Ranexa sales next year.

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.

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: 540653, ~/Articles/ArticleHandler.aspx, 10/27/2016 10:54:39 AM

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 Moments ago Sponsored by:
DOW 18,175.91 -23.42 -0.13%
S&P 500 2,134.71 -4.72 -0.22%
NASD 5,234.44 -15.83 -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

4/17/2009 4:00 PM
CVTX.DL $20.01 Down +0.00 +0.00%
CV Therapeutics CAPS Rating: **
AMLN.DL $0.00 Down +0.00 +0.00%
Amylin Pharmaceuti… CAPS Rating: **
GSK $40.37 Up +0.03 +0.07%
GlaxoSmithKline CAPS Rating: ***
LLY $76.53 Down -0.24 -0.31%
Eli Lilly and Co. CAPS Rating: ***
SNY $37.62 Up +0.56 +1.51%
Sanofi CAPS Rating: *****