FDA To Hold Advisory Committee Meeting To Discuss Potential ALS Treatment

BrainStorm Cell Therapeutics announced this week that the Food and Drug Administration (FDA) has agreed to hold an Advisory Committee Meeting (AdCom) on an undisclosed date to discuss the company’s Biologics License Application (BLA) for NurOwn as potential treatment for amyotrophic lateral sclerosis (ALS). BrainStorm also reported that it had filed an amendment to the original BLA in response to the FDA’s questions raised during its review. Previously, in November 2022, the company reported receiving a Refusal to File letter from the FDA regarding the company’s BLA for NurOwn. The proposed NurOwn therapy involves mesenchymal stromal cells which are derived from autologous bone marrow that are enriched, propagated ex vivo, and transplantated to secrete neurotrophic factors.

"The FDA provided us with more than one path to an AdCom for NurOwn. Our goal has always been to make NurOwn available to people living with ALS as quickly as possible, therefore we chose the File Over Protest pathway since this offered the fastest path to an AdCom and regulatory decision relative to other pathways provided by the FDA," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm.