We are proud to carry on metreleptin at this stage of regulation, and we look forward to working with the FDA to make this important treatment more widely available to patients with lipodystrophy, said Daniel M. Bradbury, Amylin’s president and chief administrator. The use of metreleptin for the treatment of this rare and debilitating, is another example of the enormous potential of peptides and proteins to translate science into therapies that improve the lives of patients suffering from metabolic diseases.‘And ‘disappointing that CQC is still to find weak performance in the key role to challenge discrimination and promote human rights in comparison to other areas of service delivery. We are also very concerned that only one third of the supervisory boards are the objectives of equality. People at the end of life have been discriminated against in the provision of health services and for too long.
Leptin, a hormone that fat cells plays a key role in the regulation of metabolism, was discovered in 1994 by Dr. Jeffrey Friedman of Rockefeller University in New York. Friedman has won numerous awards during his career and recently won the 2010 Lasker Award for Basic Medical Research for his work. Metreleptin , an analog of human leptin, was also studied as a potential treatment for disease and diabetes.
There is no specific treatment currently indicated for the treatment of metabolic abnormalities associated with lipodystrophy. Currently, patients receive a combination of dietary changes, lipid-lowering and antidiabetic drugs. These non-traditional therapeutic approaches to treat the cause of metabolic disturbances in lipodystrophy, and are often rendered ineffective because of the severity of the condition.
In the first part of his presentation to the bearing, the Company has presented non-clinical and clinical sections of the BLA. The company plans to submit chemistry, manufacturing and controls section of the BLA by the end of 2011, which completes the presentation.
Lipodystrophy syndromes are characterized by abnormalities in the distribution of adipose tissue with a loss of subcutaneous fat, and often appear during childhood or adolescence. Patients with lipodystrophy can have many severe metabolic abnormalities, including extreme insulin resistance, triglyceride levels are very high, difficult to control diabetes and fatty liver . These abnormalities result in a high risk of serious medical problems such as atherosclerosis damage, the vessel and the nerve accelerated by diabetes and liver, which can significantly reduce the quality of life and of life. Metreleptin therapy, a human analogue of the hormone leptin, may significantly reduce the levels of glucose and triglycerides in these patients.
If approved, would be the first treatment metreleptin specifically indicated for the treatment of diabetes and high triglyceride levels in patients with lipodystrophy, and the first approved therapeutic use of leptin.