SILVER SPRING, MD (WCMH) — The Food and Drug Administration has approved a new drug to treat patients to amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease.
This is the first new drug for the treatment of ALS in more than two decades, according to CNN.
The drug Radicava (edaravone) “is an intravenous infusion given by a health care professional,” according to the FDA. It is administered “with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.”
During a 6-month trial in Japan, the FDA says, participants on Radicava did not experience a decline in function as much as patients on a placebo.
ALS is a progressive neurogenative disease that affects the nerve cells in the brain and spinal cord that control muscle function. Awareness of the disease grew in 2014 with the social media-fueled ALS Ice Bucket Challenge.
“We hope (the) announcement signals the beginning of a new chapter in the fight against this terrible disease,” said ALS Association President Barbara Newhouse in a statement.
The company estimated that Radicava will be available in the United States this August.
The drug’s list price is $1,000 per infusion, which amounts to about $146,000 a year for treatment, according to the ALS Association.
MT Pharma says it will offer co-pay assistance for insured patients and that it has developed a program to help uninsured patients who meet certain requirements.