New drug for ALS provides hope for patients
Tuesday, May 09, 2017
Amyotrophic lateral sclerosis (ALS) is regarded as a progressive neurological condition that has the ability to destroy the nerve cells and lead to complete disability in the affected individual.
Given the debilitating nature of ALS, the recent approval of a new drug for treating ALS is considered to be a milestone. Edaravone (Radicava) is only the second drug to ever be approved by the U.S. Food and Drug Administration (FDA) for the treatment of ALS — and the first in more than two decades since riluzole gained FDA approval in 1995.
ALS was brought to the attention of the general public in 1939 by Lou Gehrig, a famous baseball player who was diagnosed with the condition, which can cause nerve cell breakdown and death. The Ice Bucket Challenge brought ALS back into the spotlight in 2014, helping to raise $115 million in donations to the ALS Association.
Both the origin and cure for ALS are still currently unknown, but there continues to be research to unlock the mystery of this condition, which affects about 12,000 to 15,000 people in the United States. People typically find out that they have this condition between 55 and 75 years of age, and the life span is about 2 to 5 years after symptom onset.
Edaravone's approval came after the benefits of the drug were demonstrated in a Japanese study. The six-month trial included 100 individuals, and was able to indicate that those participants who took edaravone experienced a reduction in the decline of their physical function by 33 percent, and even a minor decline in a daily functional activities when compared to patients who received placebo.
Once these outcomes were demonstrated, there was an immediate request for Mitsubishi Tanabe Pharma America to file for FDA approval in the United States. The goal is to have the drug available in the U.S. this August.
Edaravone was launched in Japan at $35,000, backed by a law in Japan for drug prices to be reduced each year. A year's course of the drug is expected to cost approximately $145,000 before any discounts or insurance is factored in.
The existence of edaravone offers another treatment for individuals with this chronic disorder and those who historically had only one option in riluzole. Edaravone now opens up the opportunity for additional drug developments in the future to aid with the management of this disorder, which is well known for causing paralysis and ultimately death.
The goal is to find a cure for ALS, but in the meantime steps are being taken to discover more therapies that can help to slow the progress of the condition.
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