Soleno Therapeutics has reported the death of a 17-year-old patient taking its experimental treatment Vykat XR for hyperphagia in Prader-Willi syndrome. The company said the physician determined the cause was a pulmonary embolism, unrelated to the drug. The patient had obesity and other health issues common in the disorder, which often carries serious cardiac and respiratory risks.
The case has been submitted to federal safety monitors, and Vykat remains under regulatory observation. While Soleno insists the death reflects the natural course of the disease rather than the therapy, the incident underscores both the vulnerability of Prader-Willi patients and the scrutiny experimental treatments face as they move closer to market.
