FDA Advisors Recommend Approval of New ALS Drug Act

Approval decision to be announced by Sept. 29

Diane Lilli

ALS is a vicious disease with no known cure. We've all seen tragedy unfold as victims of this neurodegenerative disease claim the lives of about 30,000 just in the US.

The new drug is AMX0035 and is reported in some studies to slow down ALS, the fatal degenerative disease that kills victims within approximately three to five years.

There are approximately 5,000 new cases of ALA diagnosed annually.  ALS is responsible for about five of every 100,000 deaths in people aged 20 or older and occurs most among persons over age 60.

Advisors in the  FDA are recommending the controversial and innovative new drug,  though AMX0035 is controversial. 

The FDA voted to move ahead with a serious discussion on approving the drug for ALS victims. The drug was denied approval in March but is now approved. The decision will be announced on September 29.

The White House Administration, on December 23, 2021,, signed a new act backed by President Joe Biden signed into law, (Public Law 117-79), the “Accelerating Access to Critical Therapies for ALS Act” (ACT for ALS)

The FDA created a comprehensive, five-year plan to tackle ALS and other neurodegenerative diseases. The FDA publicly announced its goals to  "Foster the development of safe and effective drugs that improve or extend, or both, the lives of people living with ALS and other rare neurodegenerative diseases; and facilitate access to investigational drugs for ALS and other rare neurodegenerative diseases." 

Read the FDA  plan here.