The findings of the study showed that people who have ALS had a smaller decline in their normal functioning when they took edaravone. The most common adverse events were contusion (16%), and dysphagia (13%).
Patients who have ALS have malfunctioning nerve cells, impairing both simple and complex movements such as walking, breathing, breathing, and talking.
But Mitsubishi is not alone in trying to develop a drug to treat ALS - France's AB Science reported positive late-stage data on its drug, masitinib, which is under review in Europe. It is the first new drug that has been approved by FDA for ALS treatment in 22 years.
MT Pharma America says it intends to launch Radicava in the U.S. by August, when the country will become the third market for the drug as an ALS treatment after Japan and South Korea.
"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 USA", said Eric Bastings, deputy director of the Division of Neurology Products in the FDAs Center for Drug Evaluation and Research. After over two decades, the FDA finally approved a new drug for this condition.
Meanwhile, Barbara Newhouse, president of the ALS Association, said that this is a significant time for people living with ALS.
The US Centers for Disease Control and Prevention estimates that about 12,000-15,000 Americans have ALS. By leading the way in global research, providing assistance for people with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified clinical care centers, and fostering government partnerships, The Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure.
To be marketed as Radicava in the USA, the new drug will cost $1,086 per infusion.
The drug's list price is $1,000 per infusion, which amounts to almost $150,000 a year for treatment, according to the ALS Association.
MT Pharma America is helping to make Radicava accessible to all patients who need it and has created Searchlight Support, a patient access program for people with ALS who are prescribed Radicava.
Radicava would cost $1,086 per infusion, Mitsubishi Tanabe Pharma said on Friday. It is administered with a first treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period.
An orphan drug is one that is unlikely to have many buyers, so the FDA speeds approval. The drug also has caused hives, swelling, shortness of breath and allergic reactions.