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news.The FDA has approved Amylin Pharmaceuticals and Eli Lilly's Byetta, a first-in-class treatment to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on other medications.
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Byetta (exenatide) injection is the first in a new class of medicines known as incretin mimetics and will be used to treat patients who have not achieved adequate blood sugar control with metformin and/or a sulfonylurea, two common oral diabetes medications.
“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 2 diabetes,” said Dr David Kendall, medical director at International Diabetes Center in Minneapolis, Minnesota, and an investigator for the Byetta clinical studies.
“Byetta is a truly unique tool for the management of type 2 diabetes and is an appropriate option to consider when patients cannot control their blood sugar using one or more oral medications.”
In addition to approving Byetta for use as an adjunct to existing oral medicines, the FDA also stated that Byetta is approvable as a stand-alone therapy (monotherapy) for patients with type 2 diabetes. Any additional data submitted to support a monotherapy indication is expected to receive a six-month review.
Byetta will be made available in both a 5-microgram per dose and a 10-microgram per dose prefilled pen-injector device and will be available to US pharmacies by June 1, 2005.