The Most Interesting FDA Review for 2008

It's time for large-cap pharma investors to mark their investing calendars. Last week Eli Lilly (NYSE: LLY  ) announced that the FDA had granted its top pipeline compound a priority review that could give it marketing approval in 2008.

The FDA priority review for Lilly's blood thinner, prasugrel, means that the agency should make a decision on whether to grant approval to the acute coronary syndrome treatment around June 26 (assuming a six-month review date from Lilly's Dec. 26 marketing application). This PDUFA date is the FDA's goal for making a decision on marketing approval, but the review date is not set in stone and might come before or after that date.

What makes the pending approval decision for prasugrel so interesting is that back in November, Lilly and partner Daiichi Sankyo announced somewhat mixed phase 3 data against Bristol-Myers Squibb's (NYSE: BMY  ) and Sanofi-Aventis' (NYSE: SNY  ) Plavix. For instance, in the just-announced 13,000-plus-person phase 3 trial, prasugrel outperformed Plavix on its primary efficacy endpoint (fewer deaths due to cardiac events), but it did worse on its safety endpoint (major bleeding events).

Prasugrel means a lot for Eli Lilly. Beside a long-lasting second-generation diabetes drug it is working on with partners Amylin Pharmaceuticals (Nasdaq: AMLN  ) and Alkermes (Nasdaq: ALKS  ) , prasugrel represents Lilly's best opportunity to fill in the gap from lower sales of Zyprexa once it faces generic competition in the U.S. in a couple of years.

The market is huge for any drug, like (potentially) prasugrel, that treats acute coronary syndromes. For instance, sales of Plavix surpassed $1 billion in the U.S. in the most recent quarter.

I won't try to predict what the FDA will do with prasugrel. But whatever happens in June, it will likely be the most interesting FDA ruling this year -- the FDA decision could go either way.

Read/Post Comments (0) | Recommend This Article (4)

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: 584458, ~/Articles/ArticleHandler.aspx, 10/27/2016 8:45:43 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 Moments ago Sponsored by:
DOW 18,169.68 -29.65 -0.16%
S&P 500 2,133.04 -6.39 -0.30%
NASD 5,215.97 -34.29 -0.65%

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

10/27/2016 4:01 PM
LLY $76.16 Down -0.60 -0.78%
Eli Lilly and Co. CAPS Rating: ***
ALKS $51.72 Down -1.52 -2.85%
Alkermes CAPS Rating: ****
AMLN.DL $0.00 Down +0.00 +0.00%
Amylin Pharmaceuti… CAPS Rating: **
BMY $51.96 Up +2.67 +5.42%
Bristol-Myers Squi… CAPS Rating: ****
SNY $37.25 Up +0.19 +0.51%
Sanofi CAPS Rating: *****