Posted on: 24 April 2019, source: Bloomberg
Novartis AG said the death of a six-month-old baby in a study evaluating its experimental gene therapy Zolgensma was considered by the clinical trial investigator to be potentially related to the treatment. The death of the patient with a devastating disease known as spinal muscular atrophy occurred in a late-stage trial in Europe that’s still enrolling patients, the Swiss drugmaker said in an emailed statement. Initial findings show it involved a severe respiratory infection followed by neurological complications. The results of an autopsy are pending, and details have been reported to regulators, the company said.