Earlier today the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6 to 4 against recommending AMX0035 for approval to treat people with ALS. It’s important to note that the Advisory Committee’s views are not binding on the FDA. Following the vote, the ALS Association called on the FDA to take into account the strong safety profile of AMX0035, as well as the serious unmet medical need of people living with this devastating condition, and approve the drug for clinical use.

“FDA has a choice to make – whether it will approve a drug that has been proven safe that will help people living with ALS today, or whether it will delay approval and require more evidence while more people with ALS die,” said Calaneet Balas, President and CEO of The ALS Association. “We cannot allow perfection to stand in the way of real progress toward turning ALS from a fatal disease into a livable one. The FDA’s own ALS Guidance acknowledges that people with ALS are willing to accept greater risk for the possibility of some benefit. People with ALS and their loved ones deserve better and the FDA has the tools to accomplish this with urgency.”