SAN DIEGO — Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.
Amylin said the Food and Drug Administration gave metreleptin orphan-drug and fast-track designations. The drug is designed to treat diabetes and high triglyceride levels in the bloodstream in patients with lipodystrophy, a condition known to affect a few thousand people worldwide. There currently are no drugs specifically used to treat metabolic abnormalities in patients with lipodystrophy.
“It is gratifying to see that, after years of research focused on leptin as an effective therapy for lipodystrophy, we are now closer to bringing this important and innovative medicine to patients who are in dire need of better treatments,” National Institute of Diabetes and Digestive and Kidney Diseases senior investigator Phillip Gorden said. Gorden also is the principle investigator of an ongoing National Institutes of Health study of metreleptin in lipodystrophy patients.
Amylin said it filed nonclinical and clinical sections of its application in the first part of its rolling application submission and would complete it by submitting the chemistry, manufacturing and controls sections by the end of 2011.