The Food and Drug Administration approved Radicava on Friday, a treatment for amyotrophic lateral sclerosis (more commonly known as Lou Gehrig’s disease or ALS). The approval of this drug marks the first time the FDA has approved a treatment for ALS since riluzole was released in 1995, according to CNN.
The arrival of this treatment serves as a beacon of hope for physicians and ALS advocates alike, signaling that the long halt in treatment development is finally over. The drug is intravenous, referring to the administration of the medication directly into the bloodstream through a vein. Radicava works by helping to control excessive oxidative stress in the body, which occurs at higher than normal rates in patients with ALS.
The treatment plan involves daily doses administered in two-week cycles, and each injection is projected at $1,000, coming out to $150,000 for a year of treatment. The clinical trials conducted in Japan evidenced slower disease progression for patients who received the Radicava treatment when compared to those who received a placebo.
MT Pharma, the New Jersey-based developer of the drug, expects Radicava to be available in August 2017.
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https://www.beckershospitalreview.com/supply-chain/fda-approves-1st-als-treatment-in-22-years.html