Relyvrio’s FDA expedited approbation is not without controversy. The FDAAfter a 24-week trial involving 137 patients living with ALS, Relyvrio proved to be effective. Relyvrio not only slowed the decline in daily functioning but also extended the life expectancy of patients who received it compared to those who received the placebo. According to NPRFDA will approve drug if it finds that the drug is effective in two independent studies involving hundreds of participants. A single large-scale study that demonstrates effectiveness of a drug will be approved by the FDA. “clearly positive results.”Phase 3 trials are currently in progress, involving 600 participants. However, it will not be complete until March 2024 (via). ClinicalTrials.gov).
An advisory committee working with the FDA determined that the FDA’s 24-week trial was not conclusive enough (via NPR) The committee reversed its decision and approved the drug just weeks later, in September. According to CNNRelyvrio, a monthly subscription to Relyvrio, will cost you $12,504 before insurance.
According to the ALS Research Center, ALS damages the brain and spinal cord which in turn affects motor skills. Mayo Clinic. It was first recognized internationally through the Ice Bucket Challenge. However, Lou Gehrig’s Disease is also a common name. ALS currently has no cure.