Second Patient Dies in Zafgen Obesity Drug Trial
Details of the Clinical Trial
According to Reuters, a patient receiving the obesity drug, beloranib, has died from a blockage in an artery in the lung. However, the exact cause of the first reported death back in October has yet to be determined.
In response to the patient’s death, the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the trial and suspended all clinical work on the investigational drug.
The company has been working to better understand the onset of obesity in individuals with a rare genetic eating disorder called Prader-Willi syndrome. The company says it is working with experts to better understand the incidence and the occurrence of such artery blockages in Prader-Willi syndrome patients.
Zafgen’s CEO, Thomas Hughes, said in a statement, “We remain committed to advancing beloranib as a potential new therapy for this underserved patient population.”
FDA on Other Obesity Treatments
Obesity treatments has been a tough market for drug manufacturers to crack as such treatments often result in serious safety concerns, mainly heart risks and birth defects.
Federal regulators previously approved drugs developed by Vivus Inc. Orexigen Therapeutics Inc, and Arena Pharmaceuticals Inc while requested post-marketing studies to confirm the drugs’ safety.
Most of these approved treatments work by triggering nerve signals which tell the brain that the stomach is full.