The FDA told Canada's Neurochem that it would need to see more data on Kiacta for Amyloid A amyloidosis before it could approve the therapy. The FDA says it wants new efficacy data from one or more new clinical trials unless an existing study proved persuasive. The condition is characterized by the accumulation of abnormal proteins in the body's organs.
"We are working closely with the agency to secure as soon as possible the final approval without conducting a new efficacy clinical trial. We are already starting to collect additional information as suggested by the FDA," concluded Neurochem CEO Dr. Francesco Bellini. Some analysts were skeptical, but Neurochem shares rose in early trading.
- here's the AP report on Kiacta