(RxWiki News) The US Food and Drug Administration (FDA) has approved a medication to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
This new approval is found under the brand name Radicava (edaravone). It's the first treatment to be approved for ALS in many years.
Already approved in Japan, edaravone is an additional treatment option for the 12,000 to 15,000 Americans who have ALS.
ALS, a rare disease, attacks and kills the nerve cells that control voluntary muscles involved in chewing, walking, speaking and even breathing. Over time, the muscles become weak, leading to paralysis.
Edaravone is injected into the vein by a health care provider.
The approval comes after a six-month clinical trial in Japan. The trial assessed 137 participants. By week 24, those who received edaravone saw slowed declines in daily function when compared to those who received a placebo.
Commonly reported side effects include bruising, issues with walking and headache.
Serious side effects may occur, according to the FDA. These include swelling, hives, shortness of breath and allergic reactions to sodium bisulfite, an ingredient in edaravone. These serious reactions require immediate medical care.
MT Pharma America, a US subsidiary of Mitsubishi Tanabe Pharma America, markets and distributes Radicava.