Wednesday, August 7, 2019

FDA holds groundbreaking meeting to discuss accelerating promising treatments

A new, influential patient advocacy group brought together senior FDA leadership and a biotechnology company to accelerate ALS research

WASHINGTON, D.C. – In a first-of-its-kind meeting, I AM ALS brought together senior  leadership from the Food and Drug Administration (FDA) and Brainstorm Cell Therapeutics, a U.S. biotechnology company that is developing a potential breakthrough ALS treatment, NurOwn. NurOwn has been studied in 4 clinical trials to date, and is currently the only ALS treatment nearing the end of its phase 3 clinical trial. 
Courtesy of Brian Wallach

The groundbreaking meeting was the first in-person meeting ever convened by an ALS patient advocacy group between senior FDA leadership and a biotechnology company. I AM ALS arranged the meeting to discuss Brainstorm’s ongoing phase 3 clinical trial of NurOwn as well as efforts to speed treatment access to the ALS patient community. 

The meeting enabled an open dialogue between the FDA and Brainstorm that sets the stage for future meetings to explore bringing this treatment to those living with ALS as expeditiously as possible. 

I AM ALS presented the FDA with two petitions signed by more than 20,000 individuals calling on the FDA to release its updated Clinical Trial Guidance for ALS Treatments and to approve pending ALS treatments as expeditiously as possible.

"We are hopeful that our work with senior FDA leadership and pharmaceutical/biotech companies will produce a truly impactful Guidance soon as well as real treatments for pALS," said I AM ALS Co-Founder Brian Wallach. "We are heartened to see the ALS treatment pipeline filling with small molecule, ASO, stem cell, and gene therapies. And we will do everything in our power to work with those across the pipeline to help speed these new treatments to our fellow pALS."