Radicava, also known as edaravone, has been approved for use in the United States. Up to this new FDA approval, the only other drug specifically for the treatment of ALS, commonly referred to as Lou Gehrig’s disease, is riluzole, which was approved for use back in 1995.
Results of test made in Japan showed that the drug slowed the decline of physical function by 33%. compared to placebo, said MT Pharma, the maker of edaravone.
“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,” Eric Bastings, the deputy director of the FDA’s neurology products division, said in a statement. “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.”
Radicava is an intravenous infusion that must be prescribed by a doctor and is administered in 28-day cycles.
The drug’s list price is $1,000 per infusion, which amounts to nearly $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. As soon as a person receives a prescription, he or she can access Searchlight Support, including personal case management, reimbursement support and 24/7 clinical support.
According to company’s estimation Radicava will be available in the United States this August.
What is ASL condition and the Ice Bucket Challange
ALS is a progressive, neurodegenerative disease. This disease makes the nerve cells stop working and die. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak and leads to paralysis.
ALS is also called Lou Gehrig’s disease, named after the famous baseball player who retired in 1939 because of the condition.
In 2014 the ASL gained space in the news and on the social networks thanks to the Ice Bucket Challenge which brought flood of donations that helped fund important developments in ALS research.
Source: CNN
