Radicava ORS (edaravone) vs Qalsody (tofersen)

Radicava ORS (edaravone) is an antioxidant therapy approved for the treatment of amyotrophic lateral sclerosis (ALS), designed to slow down the oxidative stress believed to play a part in neuronal degeneration. Qalsody (tofersen), on the other hand, is an investigational antisense oligonucleotide specifically targeting the genetic mutation associated with a subset of familial ALS cases caused by mutations in the SOD1 gene. While Radicava ORS is generally intended for broader use in ALS patients, Qalsody's use would be more targeted, suitable for patients with confirmed SOD1 mutations, pending its approval and evidence of efficacy and safety from clinical trials.

Difference between Radicava ORS and Qalsody

Metric	Radicava ORS (edaravone)	Qalsody (tofersen)
Generic name	Edaravone	Tofersen
Indications	Amyotrophic lateral sclerosis (ALS)	Treatment of amyotrophic lateral sclerosis (ALS) with a confirmed SOD1 mutation
Mechanism of action	Free radical scavenger that is believed to relieve effects of oxidative stress, a likely factor in the onset and progression of ALS	Antisense oligonucleotide that reduces the production of superoxide dismutase 1 (SOD1) protein
Brand names	Radicava, Radicut	Qalsody
Administrative route	Oral suspension	Intrathecal injection
Side effects	Bruising, gait disturbances, headache, eczema, dermatitis, etc.	Back pain, headache, falls, spasticity, and others
Contraindications	Patients with known hypersensitivity to edaravone or any of the excipients	Patients with known hypersensitivity to tofersen or its excipients
Drug class	Free radical scavenging agent	Antisense oligonucleotide
Manufacturer	Mitsubishi Tanabe Pharma Corporation	Biogen

Efficacy

Radicava ORS (Edaravone) Efficacy in ALS

Radicava ORS (edaravone) is an orally administered formulation of edaravone, which is a free radical scavenger that has been shown to have neuroprotective effects. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS) based on a six-month clinical trial conducted in Japan. In this trial, patients with ALS who received edaravone experienced less functional decline compared to those who received a placebo, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which assesses fine motor, gross motor, bulbar, and respiratory function.

While the exact mechanism by which Radicava ORS exerts its effects in ALS is not fully understood, it is believed to reduce oxidative stress, a condition thought to be linked to the death of motor neurons in ALS patients. The reduction in oxidative stress is hypothesized to slow the progression of the disease. However, it is important to note that Radicava ORS does not cure ALS but may help to slow the decline in physical function.

Qalsody (Tofersen) Efficacy in ALS

Qalsody (tofersen) is an investigational drug that is being developed for the treatment of ALS, particularly in patients with a confirmed SOD1 mutation, which is associated with a familial form of the disease. Tofersen is an antisense oligonucleotide designed to reduce the production of SOD1 protein, which when mutated, can be toxic to motor neurons. The efficacy of Qalsody is currently being evaluated in clinical trials.

In a Phase 1/2 open-label extension study, tofersen showed a reduction in SOD1 protein levels in the cerebrospinal fluid of patients with SOD1-ALS. Preliminary results also suggested potential slowing of clinical decline as measured by the ALSFRS-R score and other biomarkers. However, more extensive Phase 3 trials are needed to confirm these findings and to fully understand the efficacy and safety profile of Qalsody in the treatment of ALS. As of the knowledge cutoff date, Qalsody has not been approved by the FDA, and its use is limited to clinical trial settings.

Regulatory Agency Approvals

Radicava ORS

Food and Drug Administration (FDA), USA
Health Canada

Qalsody

Food and Drug Administration (FDA), USA

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