No medicine to slow the growth of ALS had been officially approved since 1995. For the first time in 22 years, the Food and Drug Administration approved a new drug for treatment of Amyotrophic Lateral Sclerosis (ALS) and to slow down functional decline in patients with (ALS). The FDA announced that Radicava, also known as Edaravone, has been approved for use in the United States. Radicava is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved to treat ALS in Japan and Korea in 2015. Promising New ALS Drug The only other drug specifically for the treatment of ALS is called Riluzole, from Rhone Poulenc Rhorer, which was approved for use in the US in 1995. The new medicine, Radicava was developed by MT Pharma America, a Mitsubishi Tanabe Pharmaceuticals. Tests conducted in Japan found that patients suffering from ALS who received Edaravone experienced a smaller decline in their level of daily functioning. The drug slowed the decline of physical function by 33%. is diagnosed in about 6,000 patients a year in the U.S.; overall, there are about 15,000 patients with the disease. Amyotrophic lateral sclerosis (ALS), commonly referred to as The Lou Gehrig’s disease and motor neurone disease (MND), is a specific disease that causes the death of neurons which control voluntary muscles. It is a disorder in which patients lose the ability to move, and eventually, to breathe. It normally affects the nerve cells in the brain and spinal cord that make muscles work. Those nerve cells lose their ability to initiate and control muscle movement, which leads to paralysis and death. ALS
Amyotrophic Lateral Sclerosis (ALS) is a neurological disease which impacts motor neurons that are involved in muscle movement throughout the body.
In the United States, ALS is called Lou Gehrig’s disease, named after the famous Yankees baseball player who retired in 1939 because of the condition and later died in 1941. The disease gained new prominence in 2014, thanks to the ALS Ice Bucket Challenge. The ALS Ice Bucket Challenge became the world’s largest global social media phenomenon. More than 17 million people uploaded their challenge videos which were watched by 440 million people a total of 10 billion times. It is now an annual event to raise awareness and funds to find treatments and a cure for (ALS). It drove $115 million dollars in donations to the to help fund important developments in ALS research, in just eight weeks. ALS Association Radicava ALS Treatment Radicava is an intravenous infusion given by a healthcare professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Radicava is an intravenous infusion that must be prescribed by a doctor. Radicava is being approved not based on extending survival, but because it made patients’ symptoms deteriorate more slowly. Radicava appears to be safe, although slightly more patients taking the drugs had bruising, alterations of their gait, or headaches. People with familial ALS live an average of only one to two years after symptoms appear. The drug is indicated for all ALS patients, without a restriction. The drug’s list price is $1,000 per infusion, which amounts to nearly $150,000 a year for treatment. The FDA gave approval of Radicava to Mitsubishi Tanabe Pharma America Inc and it is estimated that it will be available in the United States this August.