This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

FDA: Amylin Pharma Concealed Heart Safety Risks of Key Diabetes Drug

Since the active ingredient in Byetta and Bydureon is the same, Amylin asked FDA to rely on efficacy and safety data from Byetta clinical trials for part of the regulatory review of Bydureon. FDA agreed to Amylin's request.

Amylin submitted Bydureon for approval in May 2009 but FDA rejected the drug in March 2010, citing the completion of a risk management plan and resolution of some product quality issues as the only deficiencies needed to be remedied.

One month later, in April 2010, regulators with Health Canada told FDA about a "thorough QT study" of Byetta conducted two years earlier by the company. So-called tQT studies measure the effect a drug has on heart rhythm, an especially important issue to FDA given concerns about the cardiovascular safety of diabetes drugs. This tQT study of Byetta raised significant heart safety concerns for Canadian regulators.

But Amylin had never told FDA about the tQT study of Byetta and failed to include the troublesome heart-safety data in the initial Byduron approval filing. Amylin withheld these negative safety data even though Amylin agreed to supply FDA with Byetta efficacy and safety data for use in the Bydureon review, FDA's Parks charges in her memo.

"More importantly, FDA was not informed by Amylin that Health Canada considered several findings from tQT study concerning enough such that approval was delayed in Canada because agreement on product labeling could not be reached," Parks writes.

Immediately upon learning of the existence of the Byetta tQT study, FDA contacted Amylin and asked for the data to be included in the Bydureon resubmission. Amylin resubmitted its Bydureon application on April 22, 2010 but data from the Byetta tQT study were "absent" from the filing, Park states in her memo.

Instead, Amylin submitted the Byetta tQT study data separately as an addendum to the original Byetta regulatory file. Asked whether Amylin was trying to conceal potential negative heart-safety data from FDA, Amylin spokeswoman Izzo says the company notified FDA in an "appropriate manner."

Regardless of how the previously undisclosed Byetta heart-safety study was filed, FDA considered the data as part of Amylin's Bydureon resubmission. On Oct. 18, 2010, FDA rejected Bydureon a second time, in part over the safety concerns raised by the Byetta heart safety study conducted in Canada.

2 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,985.61 +78.99 0.47%
S&P 500 1,972.83 +9.12 0.46%
NASDAQ 4,419.0340 +27.5710 0.63%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs