The difficult-to-enter landscape of amyotrophic lateral sclerosis (ALS) R&D received a major boost Wednesday night from the U.S. House of Representatives as 423 of 433 legislators passed a bill that would funnel $500 million into treatments for the muscle-wasting disease.
Three ALS associations are now calling on the U.S. Senate to follow suit and pass it on to President Joe Biden’s desk. If passed, the federal government would dole out $500 million into research grants and a public-private partnership over a five-year period beginning in fiscal 2022.
The FDA and the National Institutes of Health would jointly lead a public-private partnership for rare neurodegenerative diseases if the ACT for ALS bill is passed.
Aside from providing drugmakers with cash to fund research and development in neurodegenerative diseases like ALS, the measure would also give certain patients access to investigational therapies.
“People with ALS can’t wait, and passage of this bill is urgently needed,” said Neil Thakur, chief mission officer of the ALS Association, in a statement.
The overwhelming support from Congress comes as the neurodegenerative field receives a boon in investment, especially in the months following the controversial approval of Biogen’s Alzheimer’s disease drug Aduhelm.
Closer to the bill’s core, in the ALS space, small biotech Amylyx is attempting to push its treatment into the U.S. and Canadian markets. In a reversal on its April request for a phase 3 trial, the FDA accepted the company’s submission based on phase 2 data in September. Amylyx has also asked Canadian regulators to approve the med and is slated to make a request to the EU soon. The drug, AMX0035, also went through a recent midstage test in Alzheimer’s.
For its part, Biogen thinks it can bring another failed treatment to market. The Aduhelm maker’s drug tofersen failed a phase 3 test in a subset of ALS in October, but the biopharma thinks some biomarker data can carry the investigational drug forward.