Edaravone in Europe: How to get this ALS treatment quickly
Last updated: 14 February 2024
You can legally access new medicines, even if they are not approved in your country.
Learn howEdaravone, known by its marketed names Radicava or Radicut, received FDA approval as a treatment for ALS in 2017 1. Initially, it was approved for intravenous use, but in 2022, the FDA also granted approval for its oral administration.
As of February 2024, edaravone remains unavailable in Europe or the UK, despite other countries adopting its use.
What is the impact on local patients and what are your safe and legal options to get this ALS treatment before it's widely available?
How is edaravone used in ALS treatment?
Edaravone, also known as Radicava or Radicut, is a medication used to treat Amyotrophic lateral sclerosis (ALS). ALS is a progressive neurodegenerative disease that weakens and deteriorates the nerve cells in the brain and spinal cord. Edaravone helps reduce oxidative stress, which is thought to contribute to the progression of ALS.
Edaravone is not a cure for ALS. Its effects are primarily focused on slowing disease progression rather than reversing its effects. However, it represents an important advancement in ALS treatment and offers hope to patients and their families.
How effective is edaravone for ALS based on clinical trial results?
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Intravenous edaravone efficacy
In a clinical study among Japanese ALS patients, less decline in functional ability was reported among patients treated with Radicava vs placebo. These results were observed among patients with forced vital capacity (FVC)≥80%. In other words, patients with normal respiratory function.
A subsequent post-hoc analysis also explored the effectiveness of edaravone on ALS patients with FVC under 80%. The reported results were in line with those for patients with normal respiratory function, showing significantly less functional decline compared to placebo 3.
It should, however, be noted that a meta-analysis from 2023 found no statistically significant difference between functional ability scores such as ALSAQ-40 and ALSFRS between edaravone patients and the control group 5.
Further trials are needed to fully understand the effects of edaravone on functional ability in specific patient groups and stages of the illness.
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Oral formulation efficacy
Oral edaravone (Radicava ORS) was approved by the FDA in 2022. This approval was based on a study that showed comparable levels of orally-administered Radicava in the bloodstream to the levels from the intravenous formulation of Radicava (which had already been approved in 2017). Similar efficacy between the two formulations was assumed 7.
This being said, a recent phase 3 clinical study conducted in Europe failed to demonstrate a significant benefit of oral edaravone compared to placebo 4.
Does edaravone prolong survival?
A recent meta-analysis of clinical trials involving edaravone reported a statistically significant increase in survival rate for ALS patients treated with edaravone vs placebo. This survival rate increase was noted at 18, 24 and 30 months of treatment 5.
It is worth noting that more research is needed to fully understand the effects of edaravone on prolonged survival in ALS patients, as well as to identify the specific factors that may influence its effectiveness.
Is edaravone approved in Europe?
As of February 2024, not yet. An application for the marketing authorization of intravenous Radicava was submitted but later withdrawn by the medicine's manufacturer 6. Unless a new application is submitted for intravenous Radicava's EMA approval, it doesn't seem like the medicine will be available to ALS patients in Europe any time soon.
Oral edaravone has not yet been submitted for EMA approval.
Is edaravone available in the UK?
Unfortunately, edaravone is not available in the UK yet. If an application for MHRA approval is submitted by Radicava's manufacturer, it takes approximately 210 days to review. Given a positive outcome, NICE needs to also make a decision on a potential inclusion of the medicine on the NHS. In any case, with no active MHRA approval application, edaravone does not look likely to become available in the UK soon.
Where is edaravone available in 2024?
Edaravone, marketed as either Radicava or Radicut, is currently available in the USA, Japan, South Korea, China, Canada, Switzerland, Indonesia, Australia, Malaysia and Thailand 1.
This may seem like bad news if you're an ALS patient based in a country not on this list. However, if your treating doctor wants to include edaravone in your treatment plan, there are ways to get the medicine quickly in Europe, the UK, or elsewhere where it's not available.
How you can get edaravone before its EMA and MHRA approval
While the approval process for new medicines can be lengthy and complex, you don't always have to wait.
You could either try to join a clinical trial involving edaravone, or you could buy edaravone directly as a Named Patient,
Here’s a bit about each option.
Join an edaravone clinical trial
To get quick access to edaravone in Europe or the UK, you can try joining an ongoing clinical trial. It can take some effort finding one, but it is possible. In order to participate in a clinical trial, you must meet the eligibility criteria. You will also need your treating doctor's support to be able to participate. In all cases, you should be aware that you might be on a placebo group in the trial.
Here are some good places to start looking for ongoing edaravone clinical trials:
- ClinicalTrials.gov: A comprehensive database of US clinical trials. Select trials are open to international participants, and it’s always worth keeping an eye on the list.
- EUClinicaltrials.eu: This database contains all clinical trials in the European Union. There are multiple ongoing trials involving edaravone across Europe. For trials launched before 31 January 2022, you can refer to the EU Clinical Trials Register.
- myTomorrows and FindMeCure: These organizations support patients worldwide in locating suitable clinical trials.
Buy edaravone as a Named Patient
If joining a trial isn’t an option for you, or you simply prefer not to wait, you can buy edaravone directly as a Named Patient. Most countries in the world allow patients to buy and import medicine that isn't approved or available locally yet, as long as it's for their personal use. The regulations allowing this are usually referred to as Named Patient Import regulations. In order to make use of them, you first need to have a prescription from your doctor.
Do you already have a prescription? Send it to us and we'll support you in buying edaravone quickly and safely.
How much does edaravone cost per year?
If you're considering buying a medicine that isn't available on your local market yet, you should take prices as indicative only. The final cost will likely depend on your location, the supplier, and any shipping or importation fees that might apply to safely delivery the medicine.
To give you an idea of how much edaravone costs per year, here's a breakdown of you options:
- Radicut (the Japanese brand name of edaravone). 10 vials of 30 mg/20 mL cost about EUR 1,158. The recommended treatment cycle for Radicut consists of a daily infusion for 10 days, followed by 14 days without infusion. This means that 10 vials of Radicut will approximately last you a month. Over a year's period, your Radicut treatment will cost approximately EUR 13,900.
- Oral edaravone (Radicava ORS). One bottle of 50 mL (105 mg/5 mL dose) of oral Radicava currently costs approximately EUR 33,400. A bottle will last you almost a month. Your yearly costs would add up to about EUR 400,800.
- Generic edaravone (Meiji Seika). A Japanese-produced generic version of edaravone is also available and it is often the most cost-effective option. 10 vials of 30 mg/20 mL that will last you close to a month cost approximately EUR 580 (or EUR 6,960 per year).
Final thoughts
There is no consensus on the effectiveness and survival benefits of edaravone in clinical trials. However, it may work for certain patient groups. Your treating doctor will determine if it is suitable for you. If your doctor supports edaravone as a treatment, you don't have to wait for its approval in Europe or elsewhere. Just contact our team of Medicine Access experts for help.
References:
- Edaravone. The ALS Association, Accessed 13 February 2024.
- RADICAVA (edaravone injection), for intravenous use. Accessdata.fda.gov, Accessed 13 February 2024.
- Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. NCBI, 14 June 2022.
- Negative results from Phase 3 ADORE clinical trial of Oral Edaravone (FAB122) in ALS – ALS Society of Canada. ALS Society of Canada, 31 January 2024.
- Safety and efficacy of edaravone in patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis. Neurological Sciences, 30 May 2023.
- Radicava | European Medicines Agency. European Medicines Agency, Accessed 13 February 2024.
- FDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS). FDA, 12 May 2022.
