SUBSCRIBE Blog with us: BLOGbiotech

GEN News Highlights

• Email
• Print
• Share
• More GEN News Highlights

Nov 2 2009, 10:52 AM EST

Amylin and Lilly’s Byetta Sanctioned as Monotherapy for Type 2 Diabetes

GEN News Highlights

FDA has approved Amylin Pharmaceuticals and Eli Lilly’s Byetta® for use as a monotherapy along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Additionally, the agency has updated Byetta prescribing information to include pancreatitis-related language in the warnings and precautions section.

Byetta was previously sanctioned for patients who were also taking other common diabetes medications and had not achieved adequate glycemic control. The new label also expands upon existing language regarding use of Byetta in patients with renal impairment.

The approval of Byetta as a monotherapy was based on a clinical study of patients who were unable to achieve glycemic control through diet and exercise alone. The study showed that 5 mcg or 10 mcg of Byetta reduced patients’ A1C, a measure of average blood sugar over three months, by 0.7 percentage points and 0.9 percentage points, respectively. Patients also lost 6.0 pounds and 6.4 pounds, respectively.

Lilly and Amylin each get 50% of Byetta's gross margin in the U.S., and Lilly gets 100% of sales outside the U.S. Byetta has pulled in $592.8 million through worldwide sales during the first three quarters of this year. In the third quarter alone worldwide sales reached $205.7 million, a 2% increase compared with last year’s third quarter. U.S. sales of Byetta, however, declined 5% to $171.1 million compared with the same time period last year.

 

♦♦♦
Related News
Confusing Choices for Doctors and Type 2 Diabetes Patients (Oct. 23, 2009)
Novo Nordisk's Type 2 Diabetes Candidate Fares Better in Clinical Trial than Lilly and Amylin's Marketed Drug  (June 9, 2009)
Amylin and Lilly Take Over Transdermal Exenatide from Altea (Apr. 1, 2009)
Lilly Pays $7M Upfront for Transition’s Diabetic Program (Mar. 14, 2008)
Lilly In-Licenses OSI’s Diabetes Program for $25M (Jan. 5, 2007)

• Email
• Print
• Share
• More GEN News Highlights

Comment on this News:

Name:
Title:
Comment:
	HELP US FIGHT SPAMMING ROBOTS by answering the following simple question. It will verify you as a legitimate user wishing to post a comment. Thank you for your cooperation.

CAREER CENTER

WEBINARS

PODCASTS

MOST POPULAR