Amylin’s Woes Mount, Thanks to FDA Actions

Analysts speculate that the FDA may delay until 2011 its approval of a long-acting form of Byetta called exenatide LAR. Amylin had hoped to receive approval by 2010 by the latest.

Oct 13, 2008

The stock of Byetta manufacturer Amylin Pharmaceuticals has lost more than half of its value over the past eight weeks, thanks to FDA concerns that the type 2 treatment may be connected with the deaths from acute pancreatitis of six Byetta users. Although the FDA has not proven a direct association between fatal pancreatitis and the use of Byetta, Amylin's stock has fallen nevertheless.

Adding to the company's problems is speculation among financial analysts that the FDA may delay until 2011 its approval of a long-acting form of Byetta called exenatide LAR. Amylin had hoped to receive approval by 2010 by the latest.

The long-acting form, which is administered by injection once a week, is now undergoing testing under FDA auspices. Current Byetta users inject the drug twice daily, usually before the morning and evening meals.

Third-quarter sales for Byetta are expected to reach $175 million, about $6 million to $7 million less than Wall Street forecasters had predicted earlier this year.

Byetta, which controls appetite and glucose production and stimulates beta cell growth, has been on the market since 2005. It is used by approximately 800,000 people with type 2 diabetes.  

Click Here To View Or Post Comments

Categories: Byetta, Diabetes, Diabetes, Pens, Type 2 Issues

Take the Diabetes Health Pump Survey
See What's Inside
Read this FREE issue now
For healthcare professionals only
  • 12th Annual Product Reference Guide
  • Insulin Syringe Chart
  • Insulin Pen Needles Chart
  • Fast-Acting Glucose
  • Sharps Disposal
  • Blood Glucose Meters Chart
  • Insulin Pumps Chart
See the entire table of contents here!

You can view the current or previous issues of Diabetes Health online, in their entirety, anytime you want.
Click Here To View

See if you qualify for our free healthcare professional magazines. Click here to start your application for Pre-Diabetes Health, Diabetes Health Pharmacist and Diabetes Health Professional.

Learn More About the Professional Subscription

Free Diabetes Health e-Newsletter

Top Rated
Print | Email | Share | Comments (0)

You May Also Be Interested In...


Add your comments about this article below. You can add comments as a registered user or anonymously. If you choose to post anonymously your comments will be sent to our moderator for approval before they appear on this page. If you choose to post as a registered user your comments will appear instantly.

When voicing your views via the comment feature, please respect the Diabetes Health community by refraining from comments that could be considered offensive to other people. Diabetes Health reserves the right to remove comments when necessary to maintain the cordial voice of the diabetes community.

For your privacy and protection, we ask that you do not include personal details such as address or telephone number in any comments posted.

Don't have your Diabetes Health Username? Register now and add your comments to all our content.

Have Your Say...

Username: Password:
©1991-2015 Diabetes Health | Home | Privacy | Press | Advertising | Help | Contact Us | Donate | Sitemap

Diabetes Health Medical Disclaimer

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images, and information, contained on or available through this website is for general information purposes only. Opinions expressed here are the opinions of writers, contributors, and commentators, and are not necessarily those of Diabetes Health. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website.