The U.S. Food and Drug Administration has given green signal to Bristol-Myers Squibb Co for its drug that treats rare and potentially fatal disorders that involves loss of body fat.
Myalept (metreleptin) has received FDA nod to be used as a replacement therapy for treating complications caused by leptin hormone deficiency in patients with congenital or acquired generalized lipodystrophy. The generalized lipodystrophy is a condition in which patients experience a loss of fat tissue, especially under the skin that leads to low levels of leptin.
Following directives from FDA, Bristol-Myers will conduct seven post-marketing studies on Myalept.
Myalept is a form of leptin that helps in reducing accumulation of fat in organs. This helps in controlling blood sugar and high levels of triglycerides.
Triglycerides are a type of fat in the bloodstream linked with increased heart disease risk.
Leptin deficiency causes serious imbalances in the body which lead to fat accumulation in muscles and organs like liver. It can lead to serious medical conditions like diabetes, pancreatitis and fatty liver disease.
The drugmaker had co-developed the drug with AstraZeneca.