(Corrects throughout to change source to U.S. Food and Drug
Administration from Bristol-Myers Squibb. The error also
appeared in a previous version of the story)
Feb 25 The U.S. Food and Drug Administration
said it approved Bristol-Myers Squibb Co's drug to treat
rare and potentially fatal disorders involving loss of body fat.
The drug has been approved as a replacement therapy to treat
complications caused by leptin hormone deficiency in patients
with congenital or acquired generalized lipodystrophy.
Generalized lipodystrophy patients experience a loss of fat
tissue, especially under the skin, leading to low levels of
Leptin deficiency causes serious imbalance in the body,
leading to fat accumulation in muscles and organs such as the
liver. The deficiency can lead to diabetes, pancreatitis and
fatty liver disease.
The drug, Myalept (metreleptin), is a form of leptin meant
to reduce accumulation of fat in organs to better control blood
sugar and high levels of triglycerides - a type of fat in the
bloodstream associated with increased risk of heart disease.
The FDA said it asked for seven post-marketing studies on
Bristol-Myers had co-developed the drug with AstraZeneca
(Reporting by Shailesh Kuber; Editing by Ted Kerr and Kirti