Three patient advocates share what they hope to see when it comes to ALS treatment and how the government can help.
Sandy Morris and her family visited the FDA as part of her advocacy since she has been diagnosed with ALS. She and other patient advocates wish for faster drug development for the progressive, incurable condition.Several years ago, Gwen Petersen noticed that when she walked, her left foot would catch on the ground. She kept falling and each tumble was more severe. Her balance and coordination felt off but even after repeated emergency room trips, doctors had no answers.
“We need a little sustenance,” Wallach, 41, of Chicago’s suburbs told TODAY with the help of Abrevaya. ALS makes his speaking voice sound soft. “The only thing that want is to have move faster.” "The vast majority of patients with this disease have limited access to therapies because they can’t get into clinical trials,” Abrevaya, 41, added.
Amylyx, the maker of AMX0035, said in a statement after the delay: “We remain engaged with the FDA to advance AMX0035 through the review process as efficiently as possible. We are pleased that the members of the advisory panel will review additional analyses from our clinical studies, including recently published analyses, supporting the previously reported functional and overall survival benefit for AMX0035.
The drug is currently in a phase 3 clinical trial with many patients in Europe, Paganoni explained. If the FDA does not approve its use in September, patients will have to wait for the results from the larger trial not expected until 2024, she added.Sandy Morris, who was diagnosed with ALS in 2017 when she was 51, also wishes the FDA would act with more urgency.
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