The panel’s narrow vote of rejection felt like a body blow to many ALS sufferers who’ve been lobbying for this new drug’s approval. One of them is 81-year-old Palucki, a U.S. Navy veteran from Tinley Park.
Last month, representatives from the ALS Association met with former Tennessee Congressman Phil Roe, right, in his offices on Capitol Hill in Washington. The ALS Association and other patient groups have been lobbying federal officials for over a year seeking access to an experimental drug from Amylyx Pharmaceuticals. “The lack of compassion for us by the FDA is unforgivable,” said Palucki, a U.S. Navy veteran from Tinley Park, Illinois.
“I think it would be a disservice to the patients and their families to approve a treatment that is of uncertain benefit,” Dr. Kenneth Fischbeck of the National Institutes of Health said in a statement. Sandra Abrevaya helps her husband Brian Wallach walk at their home Feb. 13, 2022, in Kenilworth, Illinois. Wallach was diagnosed with ALS, or amyotrophic lateral sclerosis, in 2017 at the age of 37 and was told he wouldn't live past his infant daughter's first birthday. He's still here, although the disease progresses every year.
The FDA released briefing documents prior to the panel’s vote, signaling its concerns about results from the new drug’s second phase study. The agency is likely planning on using this setback to seek more robust data from Amylyx with a larger size clinical trial. Company officials said the third phase should include 600 ALS patients, with a scheduled release date in 2024.Prior to Lou Gehrig’s diagnosis in 1939, ALS was a relatively unknown disease.
Palucki’s wife of 57 years, Ceil, is his caregiver. The couple met in 1963 while working together at Sears in the city.
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