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Lilly's first-in-class diabetes drug approved in US

Published on 05/05/05 at 01:25pm

Lilly has gained US marketing approval for Byetta, the first in a new class of type II diabetes treatments derived from the saliva of a rare North American lizard.

Byetta (exenatide) has been approved as an adjunctive therapy for patients who have not achieved adequate control on existing treatment metformin and/or sulfonylurea and is taken by injection after morning and evening meals.

The drug is the first incretin memetic to be approved and works by mimicking the action of naturally occurring human incretin hormone, glucagons-like peptide-1 (GLP-1).

Byetta has been shown to stimulate insulin secretion only when blood sugar is high, and can even restore the 'first-phase' insulin response, an activity of the pancreas' insulin-producing cells that is lost in patients with type II diabetes.

Clinical trials also showed the drug reduces the appetite and consequently the body weight of patients, although Lilly and Amylin, who discovered the drug, are not strongly promoting this as a benefit.

The drug is derived from the venom of the Gila Monster, a rare lizard found in the deserts of the southwest United States and Mexico, which produces a hormone which is longer-lasting than the naturally occurring human GLP-1.

Californian biotech Amylin acquired the rights from Dr John Eng in 1996 and then, in 2002, the company entered into a development deal with Eli Lilly.

The FDA has encouraged Lilly to file the drug as a monotherapy, already indicating that a submission would receive a six-month priority review.

The drug's considerable first-in-class benefits mean Byetta's peak sales could reach the $1 billion level, despite fierce competition in the growing diabetes treatment market.

"The availability of a treatment that lowers blood sugar and has the potential to help restore the response of the body's insulin-producing cells is an exciting advance for patients with type II diabetes," said Dr David Kendall, one of the lead investigators of the drug.

"Byetta is a truly unique tool for the management of type II diabetes and is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications."

Lilly expects to file the drug in Europe within the next 12 months.

In the same class as Byetta is liraglutide, a rival drug in the same class from Novo Nordisk, now in phase II development. Novo Nordisk is hoping their drug can challenge Lilly's because of a number of claimed advantages, including a once rather than twice a day injection, with no peak in its action.

A drug with a similar mechanism is Novartis' LAF-237, currently in phase III trials and expected to be filed in 2006. The drug works by blocking the action of dipeptidyl peptidase (DPP-4), an enzyme that normally inactivates incretin hormones, and phase III studies have shown the drug mimics the body's natural, physiological mechanism of balancing out insulin supply and demand.


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