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Byetta receives EU approval for Type II diabetes

Published on 28/11/06 at 04:41pm

Lilly and Amylin's new diabetes treatment, Byetta, has won EU approval.

It is the first in a new class of anti-diabetic medicines known as incretin mimetics and has been on the US market since mid 2005.

Byetta (exanatide) is now approved in Europe as an adjunctive therapy to improve blood sugar control in patients with Type II diabetes who have not achieved adequate glycaemic control on maximally tolerated doses of metformin and/or a sulfornylurea - two common oral diabetes medicines. Lilly and Amylin intend launching the drug sometime in 2007.

The drug works by mimicking the glucose-lowering effects of human hormones, called incretins, and it not only controls insulin levels, but also acts as a weight-loss agent in some patients.

More than 48 million people in Europe are estimated to have diabetes. Abbas Hussain, president of Lilly's European operations, said: "The rapid increase in the prevalence of diabetes and the need for innovative new treatments has never been more critical. The approval of Byetta is a major step forward in giving healthcare professionals and patients in EU countries a new treatment option for the management of Type II diabetes."

Prof Anthony Barnett, from Birmingham University and Birmingham Heartlands Hospital, commented: "Byetta is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications."

Prof Barnett, one of the investigators in the Byetta clinical trials, added: "The availability of a treatment that lowers blood sugar to a healthy range, lowers weight and has the potential to restore the response of the body's insulin-producing cells is an exciting advance for patients with Type II diabetes."

However, analysts believe sales of Byetta could be knocked back following recent US approval of Merck's Januvia (sitagliptin). Furthermore, although Novartis' Galvus (vildagliptin) has been delayed for US review until February 2007, after the company submitted extra safety data, Norvatis is confident it will gain approval there.

The two drugs are both dipeptidyl peptidase-4  (DDP-4) inhibitors, which work in a similar way to Byetta.The Bank of America has estimated that Januvia and Galvus could have $1.5 billion annual sales by the year 2010.


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