Bristol-Myers Squibb Company announced Tuesday that the U.S. Food and Drug Administration has approved its drug to treat rare and potentially fatal body fat disorder, Reuters reported.

The health regulator's approval of Myalept as a replacement therapy to treat complications caused by leptin hormone deficiency in patients is based on data from Bristol-Myers Squibb Company's ongoing Phase III clinical trial program, Reuters reported.

"We are pleased that Myalept will be available to patients in the U.S.," Briggs Morrison, executive vice president, global medicines development and chief medical officer of AstraZeneca, said in a statement. "Myalept is the first approved therapy, as an adjunct to diet, to help treat the complications of leptin deficiency affecting the lives of children and adults with generalized lipodystrophy."

Generalized lipodystrophy patients usually experience a loss of fat tissue, especially under the skin, leading to low levels of leptin.

Low levels of leptin or leptin deficiency causes serious imbalance in the body, leading to fat accumulation in muscles and organs such as the liver. The deficiency can also lead to diabetes, pancreatitis and fatty liver disease, Reuters reported.

Myalept is a form of human leptin meant to reduce the accumulation of fat in organs to better control blood sugar and high levels. It is the first and only treatment approved by the FDA for these patients.

The drugmaker said the FDA had asked it to conduct seven post-marketing studies on Myalept.

The drugmaker had co-developed the drug with AstraZeneca.