FDA gives go-ahead for new diabetes treatment

May 1 2005

Sufferers from adult-onset diabetes, the most common form of the disease, will soon be able to access a new injectable diabetes treatment which when used with oral drugs, should be more effective in controlling their blood sugar.

The drug - Byetta, produced by Amylin Pharmaceuticals and Eli Lilly won U.S. regulatory approval of the new injectable diabetes treatment when used with oral drugs.

The company says the drug will be used as a twice-daily injection for patients with adult-onset diabetes who cannot control their blood sugar with pills alone.

Such patients usually need insulin injections which must be carefully worked out to avoid lowering blood sugar excessively. Unlike insulin injections, Byetta's effect kicks in when glucose levels are high and neutralizes when they fall to normal, researchers say and is the first in a new class of medicines for diabetes.

The Food and Drug Administration said additional data would probably qualify Byetta as "approvable" for stand-alone use, which is what many investors hoped for as the drug is expected to generate more than $1 billion a year in revenue, according to analysts, and may well become the next treatment for as many as 6 million patients who presently take other drugs.

Amylin CEO Ginger Graham says Byetta will be available to pharmacies by June 1.

A 30-day supply of the drug, sold in a pen-like injection device, will be $147 or $172.50 depending on the dosage.