U.S. FDA advisory panel partially backs drug for rare fat disorder
Dec 11 (Reuters) - An advisory panel of medical experts convened by the U.S. Food and Drug Administration on Wednesday voted that Bristol-Myers Squibb Co had provided adequate evidence of the benefits of an experimental drug to treat rare and potentially fatal disorders involving loss of body fat.
The panel voted 11-1 that the benefits of the drug metreleptin outweigh the risks for the treatment of children and adults suffering from a condition known as generalized lipodystrophy.
Only a few thousand people worldwide are believed to have the disorders, in which fat builds up in the blood and organs such as liver and muscle, and can lead to diabetes, pancreatitis and fatty liver disease. There are currently no approved drugs to treat the underlying causes of the disease, including deficiencies of the human hormone leptin that occur with loss of fat tissue under the skin.
However, by a 10-2 vote, the panel felt the risks of the medicine were too high to recommend the drug for metabolic disorders associated with partial lipodystrophy, such as diabetes and high triglycerides inadequately controlled by a current therapy.
The FDA typically follows the advice of its expert panels but is under no obligation to do so.
- Man called Bitcoin's father denies ties, leads LA car chase
- Ukraine standoff intensifies, Russia says sanctions will 'boomerang' |
- Malaysia Airlines loses contact with plane carrying 239 people
- Florida mayor fights backyard gun ranges in 'Gunshine State'
- Apple loses bid for U.S. ban on Samsung smartphone sales