The Food and Drug Administration has extended the timeline of its review of AMX0035, a drug shown to be safe and effective for the treatment of ALS, citing additional data further showing that it is effective at reducing harms associated with the disease such as hospitalizations and tracheostomy.
While a decision on whether or not to approve the therapy was originally scheduled to be made by June 29, the FDA has pushed the time frame out an additional three months to September 29.
The ALS Association has released the following statement in response to the news:
“The FDA appears to be taking additional time so it can consider the additional positive data that has come out about the effects of AMX0035. We believe the FDA needs to approve AMX0035 as quickly as possible. Americans living with ALS deserve a fast and responsive FDA that enables them to access treatments that have been proven safe and effective.”
The FDA also recently received a letter signed by several dozen prominent ALS clinicians asking for AMX0035 to be approved so they can work with their patients to determine whether the treatment is right for them.
To urge the FDA to approve AMX0035 as quickly as possible go to als.org/fda.