This morning we joined other ALS organizations releasing an open letter urging the FDA to quickly approve AMX0035.
“The case for approval in the United States – especially given the recent approval of AMX0035 by Health Canada – is clear, and the time is now. We urge the FDA to act swiftly to complete its review in advance of a recently extended decision deadline and approve AMX0035,” we wrote in the joint letter released today.
Today is an important day underscoring the need for greater urgency: the FDA was originally scheduled to reach a decision on approval no later than today. A few weeks ago, they extended the time period for review by 3 months to consider additional data.
Since that time, health officials in Canada approved the therapy for the treatment of ALS in that country, creating even greater need for swift action from the FDA making sure the drug, which is safe and effective, available here.
Already there are reports of people with ALS from the United States contemplating traveling to Canada to access the drug once it becomes available, a process known as medical tourism.
To urge the FDA to act swiftly, go to ALS.org/FDA.