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FDA Approves First New ALS Drug in 22 years

 

On May 5, the Food and Drug Administration (FDA) approved a new drug called Radicava—its first approval in over two decades of a drug to treat amyotrophic lateral sclerosis (ALS).

 

The only other drug approved by the FDA for use specifically for the treatment of ALS is riluzole, which got the federal green light in 1995.

 

Tests conducted in Japan found that ALS patients given Radicava experienced a smaller decline in levels of daily functioning compared to those given placebos. According to drugmaker MT Pharma, the drug slows the decline of physical function by 33 percent.

 

Amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease, is a progressive, neurodegenerative condition in which nerve cells controlling muscles gradually lose their ability to initiate and control movement.  The terminal illness currently has no cure.

 

Radicava is an intravenous infusion that must be prescribed by a doctor and is administered in 28-day cycles.  The drug’s list price is $1,000 per infusion, which amounts to nearly $150,000 a year for treatment, according to the ALS Association.

 

Manufacturer 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.

 

The company estimates that Radicava will be available in the U.S. this August.