Bydureon has been given a positive opinion by CHMP (the Committee for Medicinal Products for Human Use), part of EMA (the European Medicines Agency) for type 2 diabetes treatment in combination with other medications. The injection is aimed at patients whose glycemic control has not responded well to maximum doses of oral drugs. On approval, it will be the first once-weekly type 2 diabetes treatment.

Bydureon has been created by three pharmaceutical companies – Elli Lilly and Company, Amylin Pharmaceuticals Inc., and Alkermes Inc.

The European Commission makes the final decision on approval. However, it generally goes along with CHMP’s recommendations.

Enrique Conterno, president, Lilly Diabetes, said:

“The CHMP’s positive opinion is a pivotal step toward marketing authorization for BYDUREON in Europe. If approved, BYDUREON will offer patients the benefits of a GLP-1 receptor agonist in a once-weekly injection. We remain deeply committed to advancing the treatment of diabetes through innovative treatment options and solutions that meet the specific needs of millions of people living with diabetes.”

In the submission package, CHMP reviewed data from the DURATION clinical program which demonstrated improved glycemic control when patients were given exenatide once a week.

In a communiqué issued today, Eli Lilly wrote:

“In the data submitted, BYDUREON showed statistically significant improvements in glycemic control based on reduction of A1C, a measure of average blood sugar over three months, between 1.5 and 1.9 percent after six months.”

Most of the patients in the study who were on Bydureon lost weight, even though this was not one of the study’s endpoints.

Side effects included mild-to-moderate nausea, vomiting, diarrhea and constipation. Nausea affected 20% of patients.

Approval is being sought for Bydureon, once weekly 2mg dose, in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione.

Submission was made to the FDA (Food and Drug Administration), USA, in 2009. The FDA issued a CRL (Complete Letter Response) in which it asked for more data. The three companies say that later on this year they will submit a response.

Eli Lilly wrote:

BYDUREON belongs to the class of glucagon-like peptide-1 (GLP-1) receptor agonists. With just one weekly dose, a continuous release of exenatide is delivered using Medisorb®, a biodegradable microsphere technology developed by Alkermes.

Approximately 285 people are thought to be affected by diabetes globally, and 26 million in the USA. Diabetes type 2 represents about 95% of diabetes cases.

The CDC (Centers for Disease Control and Prevention), USA, says that about 60% of diabetes patients do not achieve their target glucose levels through their current treatments. 85% of diabetes type 2 patients are overweight while 55% are obese.

Written by Christian Nordqvist