How Radicut Compares to Other ALS Medications

1. How Radicut Compares to Other ALS Medications Amyotrophic Lateral Sclerosis: Introduction Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disorder that causes motor neuron degeneration, leading to muscle weakness and respiratory failure. As the disease progresses, it brings about increasing weakness and difficulty with everyday functions. While there is no known cure yet, several medications that help in symptom management, and thereby improvement in quality of life of the patients, are available.1 Let’s take a closer look at the treatment options available for ALS, and how Radicut stands out among them. Current Treatment Options At present, there are three pharmaceutical compounds approved to slow down disease progression in ALS – riluzole, edaravone and the more recent sodium phenylbutyrate/taurursodiol – though their availability differs by country.2 Each of the approved drugs targets specific mechanisms believed to contribute to ALS. Riluzole works primarily by reducing excess glutamate (a brain chemical), while edaravone acts as an antioxidant that scavenges free radicals, aiming to reduce oxidative stress and neuroinflammation. Sodium phenylbutyrate/taurursodiol, the most recently introduced compound, focuses on reducing neuronal cell death by addressing endoplasmic reticulum stress and mitochondrial dysfunction. While these therapies provide measurable benefits, their effects remain modest, and oxidative stress and managing glutamate levels are currently the only pathways targeted by available medications.2 Given these limitations, supportive and palliative care continue to play a central role in ALS management. Interventions such as physical, occupational and speech therapy, nutritional support, and ventilation strategies help patients maintain autonomy and improve their quality of life.4 Radicut: A Well-Studied Treatment Option for ALS How Does It Work?

2. Radicut (edaravone) is a medication approved for the treatment of ALS.4 It is specifically designed to help slow the progression of the disease rather than just manage its symptoms.2 Although its exact mechanism isn’t fully understood, Radicut is believed to be effective due to its antioxidant properties. Oxidative stress contributes to the damage and death of motor neurons in ALS. Radicut may help protect these nerve cells and thereby delay the advance of the condition.2 Efficacy Data from Clinical Trials Since its approval for the treatment of ALS in Japan and Korea in 2015 and by the US FDA in 2017, edaravone (Radicut) has been increasingly used in clinical settings. It is available in both oral and intravenous formats, and its safety and efficacy have been studied in several trials, with promising results.5 In a Japanese study with 45 ALS patients, those treated with edaravone for an average of 26.6 months had a survival rate (median survival) of 49 months compared with 25 months in the control group, showing a considerable survival benefit.5 Similarly, a Korean study reviewing the long-term use of edaravone in 16 patients between 2015 and 2021 reported that the drug was generally well tolerated, with only mild side effects observed.5 Further analysis has suggested that edaravone may also benefit specific patient groups, such as those with more severe disease, longer disease duration or slower progression. Taken together, clinical trial data highlight both the potential and the variability of edaravone’s effectiveness, with results differing considerably depending on patient populations and healthcare settings.5 Neuroprotective Benefits and Patient Outcomes Edaravone, an FDA-approved treatment, has introduced additional therapeutic potential by targeting oxidative stress, a key factor in neuronal death. By preventing this damage, edaravone helps hinder the progression of motor function deterioration and may improve morbidity and mortality associated with ALS.5 Dosage, Administration and Monitoring Guidelines The recommended dose of edaravone is 60 mg administered via a 60-minute intravenous (IV) infusion once daily for 14 days as the initial treatment cycle, followed by a 14-day drug-free period. Subsequent treatment cycles consist of once-daily dosing for 10 out of 14 days, each again followed by a 14-day drug-free interval.

3. The infusion rate is approximately 1 mg (3.33 mL) per minute. The manufacturer advises that no other medications be injected or mixed with edaravone in the infusion bag.4 Edaravone is contraindicated in patients with known hypersensitivity to the drug or to other ingredients in the product. Patients should be carefully monitored for hypersensitivity reactions, such as redness, wheals and symptoms of anaphylaxis such as urticaria, decreased blood pressure and dyspnea. If hypersensitivity reactions occur, edaravone should be discontinued, and patients should be managed and monitored until the condition resolves.4 Since edaravone contains sodium bisulfite, patients should also be monitored for sulfite-related allergic reactions, including anaphylactic symptoms. Although the overall prevalence of sulfite sensitivity is unknown, it is more common among individuals with asthma.4 Side Effects: What Patients and Caregivers Should Know Edaravone is generally considered safe, with most side effects being mild and reversible, but there are some important points for patients and caregivers to keep in mind.5 The drug is contraindicated in people who have a history of hypersensitivity reactions to edaravone. If such reactions occur, treatment is stopped immediately, and the patient is managed symptomatically until the effects wear off. Since edaravone contains sodium bisulfite, sulfite-associated allergic reactions and even anaphylaxis are possible; therefore, monitoring during treatment is essential.2 The most common side effects reported with edaravone include bruising, gait disturbances and headaches. Some patients may also experience skin-related issues such as itching, blisters, rash, dermatitis or reddening, while a few cases of glycosuria (excess sugar in the urine) have been noted.5 Data on risks during pregnancy or breastfeeding remain unknown. No additional precautions have been advised for elderly patients, and the drug is not contraindicated in those with renal or hepatic impairment.5 Radicut vs. other ALS treatments Currently, these drugs hold FDA approval for the treatment of ALS: edaravone (Radicut),Riluzole and sodium phenylbutyrate/taurursodiol. While all aim to slow disease progression, they work in different ways. Edaravone has been found to slow the decline in forced vital capacity (FVC; compared to placebo) and thereby preserve lung function, and its antioxidant properties help reduce complications and mortality. Riluzole acts by regulating glutamate levels, slowing progression with lower efficacy

4. and providing only a moderate survival benefit. In contrast, sodium phenylbutyrate/taurursodiol is designed to reduce neuronal death by simultaneously lowering stress in the endoplasmic reticulum and improving mitochondrial function, two processes thought to play a role in ALS progression. 5,6 When directly compared, edaravone (Radicut) is more effective in slowing early disease progression than Riluzole. Its safety profile is also notable, as severe adverse effects, death and treatment discontinuation were found to be the same or lesser than with placebo, though mild side effects such as constipation, dysphagia and contusion can occur.5Accessing Radicut in India Under the Named Patient Program In India, Radicut (edaravone) is not commercially available but can be accessed legally through the Named Patient Program. This pathway allows patients diagnosed with ALS to obtain Radicut with the support of their treating physician, ensuring access to therapies that are otherwise unavailable in the local market. Rx4U guides patients and caregivers through every step of this process, from documentation and regulatory approvals to importation and delivery, making access to Radicut smoother, faster and reliable. FAQs on Radicut and the ALS Treatment Landscape • What are the FDA-approved drugs for ALS? Edaravone (Radicut), sodium phenylbutyrate/taurursodiol and Riluzole are the FDA-approved drugs for ALS.5 How does edaravone help in ALS? Edaravone slows motor function deterioration by reducing oxidative stress, helping improve survival and outcomes.3,5 What are the common side effects of edaravone? Constipation, dysphagia and contusion are the most reported side effects of edaravone.5 How is edaravone given? It can be taken as an IV infusion or oral suspension, usually in 28-day treatment cycles with drug-free breaks.5 •Can I access Radicut in India? Yes, Radicut can be accessed through the Named Patient Program, with support from services like Rx4U. • • • Note:

5. The information provided is for education purpose only and is subjected to prescribing information of the drug and the guidance of your treating physician. Always consult your health care provider before making any medical decision for starting your treatment. Disclaimer: Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import. References 1.Brotman RG, Moreno-Escobar MC, Joseph J, et al. Amyotrophic lateral sclerosis. [Updated 2024 Feb 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK556151/ 2.Tzeplaeff L, Wilfling S, Requardt MV, Herdick M. Current state and future directions in the therapy of ALS. Cells. 2023;12(11):1523. doi:10.3390/cells12111523 3.Cho H, Shukla S. Role of edaravone as a treatment option for patients with amyotrophic lateral sclerosis. Pharmaceuticals (Basel). 2020;14(1):29. doi:10.3390/ph14010029 4.Cruz MP. Edaravone (Radicava): a novel neuroprotective agent for the treatment of amyotrophic lateral sclerosis. Pharm & Ther. 2018;43(1):25-28. 5.Neupane P, Thada PK, Singh P, et al. Investigating edaravone use for management of amyotrophic lateral sclerosis (ALS): a narrative review. Cureus. 2023;15(1):e33746. doi:10.7759/cureus.33746 6.Paganoni S, Macklin EA, Hendrix S, et al. Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis. N Engl J Med. 2020;383(10):919-930. doi:10.1056/NEJMoa1916945