How Radicava works
Radicava is a free-radical scavenger. Free radicals are byproducts of normal cellular processes that produce energy. They are normally quickly removed by the body, but if they remain they can cause oxidative stress, leading to damage and cell death.
Oxidative stress caused by free radicals is thought to be one of the causes of nerve cell death in ALS. For example, in some patients with familial ALS, an enzyme that removes free radicals, SOD1, is mutated and no longer works.
Radicava has a neuroprotective effect and slows the progression of ALS by removing free radicals in the nervous system.
Radicava in clinical trials
The FDA’s approval of Radicava was based on the results of a double-blind, randomized, placebo-controlled Phase 3 clinical trial (NCT01492686), which evaluated the effectiveness and safety of Radicava in treating ALS. After a 12-week observation period, 137 participants were divided into two groups. Those in the first group received 60 mg of Radicava intravenously on a specified schedule, and those in the second group received a placebo, both for six months.
The primary objective of the study was improvements in ALS functional rating scale-revised (ALSFRS-R) a measure of disability progression. Although the rate of progression varies among patients, research has shown that people with ALS lose an average of one point per month on this scale.
After six months of treatment, those who received Radicava experienced a 33 percent less decline in the ALSFRS-R score compared with those in the placebo group. That figure was considered statistically significant, and researchers concluded that Radicava significantly reduces the progression of disability in ALS patients. The results of this study were published in the scientific journal The Lancet Neurology.
The most common adverse reactions from the treatment were walking problems, bruises, and headaches.
The results of a literature review of Radicava treatment were presented at the 2019 American Academy of Neurology (AAN) annual meeting. Three studies with a total of 368 ALS patients were included in the analysis where patients received either Radicava or a placebo. The analysis showed no statistically significant differences in adverse events between patients receiving Radicava and those receiving a placebo. Moreover, the Radicava-treated group showed less decline in the ALSFRS-R score. The authors concluded that Radicava is safe and can slow functional decline in ALS patients.
Radicava is administered intravenously (into the bloodstream) in 28-day cycles. The treatment starts with a patient receiving the therapy for 14 consecutive days, followed by a two-week treatment-free period. Patients then receive an infusion during 10 of the next 14 days, followed by a two-week treatment-free period.
Patients are prescribed 60 mg of Radicava per treatment, and each treatment takes 60 minutes to administer.
It is important that patients make their healthcare provider aware of other medical conditions they may have, such as asthma or allergies to other medicines, which could lead to complications. They also should let their providers know if they are pregnant or plan to become pregnant, or if they are breastfeeding or plan to breastfeed.
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