FDA Approves Edaravone Drug for Amyotrophic Lateral Sclerosis

The approval of the intravenous drug edaravone for the treatment of amyotrophic lateral sclerosis (ALS) by the US Food and Drug Administration brings hope to the 12,000 to 15,000 people suffering from the rare neurological disorder in the United States. The FDA had previously approved the drug called riluzole for the treatment of ALS. Riluzole prevents nerve damage by reducing the level of a chemical called glutamate released by nerves. Riluzole has been found to improve survival in ALS patients but does not reverse the damage already caused by the disease.

Edaravone Drug Approval

The FDA has recently approved another drug called edaravone for the treatment of ALS. Edaravone reduces oxidative stress, which can damage nerves, and slows down the progression of the condition.

Edaravone was previously approved in Japan and South Korea in 2015 for ALS. It has been found to reduce progression of symptoms when administered intravenously in the prescribed doses. It is administered in cycles, initially daily for 14 days, followed by a 14-day break, with doses in later cycles limited to days 10 and 14, with 14-day breaks.

Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said, “After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States.”

“This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”

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It must be noted that edaravone is not without side effects. It can cause allergic reactions due to its sodium bisulfite additive, as well as bruising and gait disturbances. Further studies on ALS will hopefully offer more solutions to the problems put forth by the rare disorder.

Amyotrophic Lateral Sclerosis (ALS)

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Amyotrophic lateral sclerosis (ALS), also called Lou Gehrig’s disease, is a progressive nervous disorder affecting motor nerves that control the function of voluntary muscles. Voluntary muscles are muscles that bring about movements like the lifting of the hands and feet, eating, swallowing and talking. The diaphragm that divides the thorax and the abdomen and controls breathing, is also a voluntary muscle and can get paralyzed by Lou Gehrig’s disease, resulting in respiratory failure and ultimately death.

ALS currently does not have a cure, though patients are provided with supportive treatments, and medications to treat symptoms like muscle pain and excess salivation. Physical therapy and speech therapy help the patient to cope with the problems they face as the disease progresses. Advanced cases require nutritional and breathing support.

References:

1. What is amyotrophic lateral sclerosis? - (https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet)
2. FDA approves drug to treat ALS - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm)

Source-Medindia