Take the Diabetes Health Pump Survey
See What's Inside
Read this FREE issue now
For healthcare professionals only
  • 12 Tips for Traveling With Diabetes
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
Latest
Popular
Top Rated
Diabetes Archives
Print | Email | Share | Comments (2)

Amylin Hopes to Begin U.S. Sales of Long-Acting Byetta Early This Year


Mar 4, 2010

The new product, called “once-weekly exenatide,” will require one injection every seven days.

Amylin Pharmaceuticals has announced that it expects to begin selling a once-weekly version of its diabetes drug, Byetta, by the end of the year. The company reports that the FDA is nearing final inspections of its manufacturing plant and could give the go-ahead for U.S. sales in early March.

Byetta, the commercial name for exenatide, is an injectible drug that increases insulin sensitivity, slows glucose production, and decreases appetite. Introduced in 2005, the drug has been used by several hundred thousand people, many of whom have reported dramatic weight loss while taking it. Users typically inject Byetta twice daily, once before their morning meal and once before their evening meal. The drug is usually used in conjunction with other diabetes therapies, such as metformin or sulfonylureas, but has been available since late 2009 as an FDA-approved monotherapy.

Amylin, which developed Byetta in conjunction with Eli Lilly and Co., has been looking for a more convenient way to deliver the drug ever since introducing it. The new product, called "once-weekly exenatide," will require one injection every seven days, a far simpler and less uncomfortable routine. 

One hurdle Amylin had to overcome in developing a long-term version was ensuring that the time-release technology used to  deliver Byetta at specific intervals during the week was reliable and robust. A larger hurdle has been FDA concerns about Byetta's possible role in causing pancreatitis, a painful and debilitating inflammatory condition that in some cases ends in death. Although the FDA concerns have led to stronger warning language on the drug's label, the statistical evidence has not been strong enough to prove causation. As a result, Byetta remains on the market, with more than 900,000 U.S. users.

Still, the company is concerned that FDA worries about a possible link to pancreatitis could slow the approval of long-acting Byetta. On the other hand, the FDA's recent approval of Novo Nordisk's Victoza, an injectible drug for type 2 diabetes that is chemically very similar to Byetta, may indicate that the agency is inclined to approve once-weekly exenatide. 

San Diego-based Amylin, which took a financial hit from the pancreatitis concerns about Byetta and the introduction of rival drugs, is hoping that its long-term version will increase sales and attract patients who are tired of daily injections. The company and its partner, Eli Lilly and Co., believe that U.S. sales of the drug could reach $2 billion by 2015, compared to a projected $900 million in sales for Victoza in the same year. U.S. sales of Byetta in 2009 were an estimated $790 million.   

 * * *

Sources:

Reuters press release

IBJ.com article


Categories: Byetta, Diabetes, Diabetes, Government & Policy, Insulin, Novo Nordisk, Type 2 Issues



You May Also Be Interested In...


Comments

Posted by Anonymous on 6 March 2010

Another misleading headline.

Posted by Anonymous on 12 March 2010

I was excited about this drug until my doctor showed me the manipulations i will have to go through prior to injecting as well as the needle size. Once weekly is not worth all of that. He is going to switch me from Byetta to Victaza (sp) next week. He tells me its once a day and better control and weight benefits. Does anyone know anything about this new insulin?


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:
Comment:
©1991-2014 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.