Did you know that the first drug treatment for ALS–Riluzole–was approved by the FDA in 1995? Twenty-two years later, the second drug–Radicava–was approved.
ALS was first identified in 1869. It took more than a century for these first two treatments to be approved, and neither provide a cure. In fact, many ALS patients opt not to be treated by either drug since they have wide-ranging efficacy in ALS patients. At best, they extend survival for patients in the early stages of the disease or extend the time until a tracheostomy (breathing tube in the throat) is needed.
Knowing this history helps to understand the momentum that has built in the last year thanks to patient-led advocacy and support from readers like you. In that short time, the number of approved treatments for ALS has doubled; both Relyvrio and Qalsody have been approved by the FDA since September 2022.
A meeting happening next month could lead to a third new drug approval and one of the most promising to date: debamestrocel (a.k.a. NurOwn) by the end of 2023.
On September 27, 2023, the FDA will host a public advisory committee meeting (AdComm) for BrainStorm Cell Therapeutics’s stem cell therapy NurOwn for ALS. At the AdComm, a panel of experts will review and evaluate the data provided by BrainStorm about NurOwn’s safety and efficacy and provide input that will help inform the FDA’s ultimate decision about NurOwn’s Biologics License Application.
The deadline for FDA’s approval decision (the “PDUFA” date) on NurOwn after this AdComm is currently set for December 8, 2023.
Please submit written comments to the FDA in support of NurOwn’s approval.
Your comments must be submitted by Sept. 20 for them to be included in the packet of materials provided to the members of the AdComm panel prior to their Sept. 27 meeting.
The team at I AM ALS has prepared a comprehensive guide to walk you step-by-step through the process of submitting comments to the FDA.
After you submit your comments, we challenge you to invite three more people to do the same and share the link widely on any social networks you engage in.
We’ll share more about this particular treatment and other updates in the coming weeks!