There is an urgent need for the FDA to approve NurOwn, a groundbreaking treatment that offers hope to thousands suffering from Amyotrophic Lateral Sclerosis (ALS). ALS, commonly known as Lou Gehrig’s disease, is a devastating condition that affects nerve cells in the brain and spinal cord, leading to loss of muscle control. This aggressive disease affects approximately 30,000 people in the United States alone, with thousands more diagnosed each year according to the ALS Association.

NurOwn, developed by Brainstorm Cell Therapeutics, has shown promising results in clinical trials, offering patients a potential lifeline. The treatment involves using mesenchymal stem cells to secrete protective factors that support and enhance the survival of nerve cells. Initial studies have demonstrated not only safety but also efficacy, as many participants revealed improvements in their functional capabilities.

Despite these promising results, bureaucracy and protracted approval processes have delayed the widespread availability of this critical treatment. The ALS community, alongside medical professionals and advocates, have voiced their frustration over these hurdles. Given the progressive nature of ALS, every moment lost waiting for effective treatments counts against patients battling this relentless disease.

The approval of NurOwn could not only improve the quality of life for individuals diagnosed with ALS but could potentially extend their lives. Experts in the medical field assert that the evidence supporting NurOwn justifies its approval, emphasizing the treatment's ability to meet critical unmet needs in ALS care.

The ALS community submitted a Citizens' Petition asking the FDA to review and approve NurOwn based on the totality of evidence. We call on the FDA to fast-track the approval process for NurOwn, recognizing both the severe unmet medical needs and the compelling clinical evidence provided. This decisive action would align with the FDA’s commitment to accelerating the availability of treatments for life-threatening conditions.

To support approval, petitioners are asking the FDA to review new evidence and meaningful endpoints from the entire therapy development process. A few critical areas of consideration are:

1. Expanded Access Program (EAP) data, including supportive data on respiratory preservation, survival, and biomarkers. 
2. Data from circumstances where NurOwn was accessed via Right to Try. 
3. The totality of evidence derived from all patients who received NurOwn, including those who received multiple doses, and the affects of NurOwn on areas not measured by ALSFRS-R.

Stand with us in urging the FDA to take swift action. By signing this petition, you are supporting a transformative step towards providing ALS patients with a viable treatment option. Your signature can be a light of hope for thousands who have long awaited a breakthrough.

Please join us in this critical advocacy by signing this petition now.