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.
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
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.
Bristol-Myers said the FDA had asked it to conduct seven
post-marketing studies on Myalept. (http://r.reuters.com/jam27v)
[to top of second column]
The drugmaker had co-developed the drug with AstraZeneca.
(Reporting by Shailesh Kuber; Editing by
Ted Kerr and Kirti Pandey)
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