On Wednesday, September 27, the Federal Drug Administration hosted a public Advisory Committee (AdCom) to review the approval of NurOwn (Debamestrocel) for the treatment of ALS.
Developed by Brainstorm Cell Therapeutics, NurOwn is an autologous, adult stem cell therapy based on a differentiation method which reprograms bone marrow-derived mesenchymal stem cells (MSC) into highly specialized, neuron-supporting cells. It is developed based on NurOwn cell therapy platform.
The FDA voted that the data presented on September 27 was not sufficient to demonstrate efficacy in treating patients with mild to moderate ALS. The agency is expected to make a final decision on the treatment by its scheduled Prescription Drug User Fee Act date of December 8, 2023.
“The AdCom discussion was a critical next step in the process of developing viable therapies,” said Audra Hindes, MSEd, MHC, VP of Care Services. “While the FDA’s vote was disappointing, Golden West will continue to advocate for the ALS community and push to advance promising treatments and research.”
Watch the FDA’s September 27 AdCom committee meeting to hear the conversation and for more details on their decision. Golden West will provide up-to-date information as it becomes available.