What you need to know
For the first time in 22 years, the US Food and Drug Administration (FDA) has approved a drug to treat patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease; a motor neuron disease characterised by muscular atrophy and weakness.
Radicava, commonly referred to by its generic name edaravone, was approved to treat ALS by Japan’s regulatory agency, the Pharmaceutical and Medical Device Agency (PMDA), in June 2015, and has already been available to ALS patients in Japan for almost 2 years under the brand name Radicut.
What are Radicava and Radicut (edaravone)?
Edaravone, the active ingredient in Radicava and Radicut, acts as a free radical scavenger and prevents oxidative stress damage to neurones, slowing down the decline of loss of function in ALS patients, and can be administered intravenously by a health professional.
What is the difference between Radicava (US) and Radicut (Japan)?
Radicava and Radicut contain the same active ingredient – edaravone. The only difference is that Radicava does not require dilution, whereas Radicut needs to diluted with saline before being administered.
Radicava, distributed by MT Pharma America, Inc, is supplied in single-dose polypropylene bags containing 30 mg / 100 mL clear, colourless, sterile solution for intravenous infusion (no dilution needed). Each 60 mg dose should be administered as two consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute).
Radicut, distributed by MT Pharma Japan, is supplied in single-dose vials containing 30 mg / 20 mL clear, colorless, sterile solution. Before the infusion, it should be diluted with an appropriate volume of physiological saline. Two vials are needed for one infusion. (Head to our product page for more information about standard dosage instructions.)
*Amendment – Since this blog was written we’ve discovered that it’s also possible to source Radicut in 30 mg /100 mL intravenous bags as well. Visit our product page for more information.
How does edaravone work?
Whilst edaravone is not a cure for ALS, it is significant because of its potential to slow down the progression of the disease. (Direct links to scholarly articles addressing the safety and efficacy of edaravone can be found at the bottom of an earlier article published in 2015).
Are there any side effects to using edaravone?
The most common adverse reactions reported by clinical trial participants receiving edaravone were bruising (contusion) and gait disturbance.
When will I be able to access Radicava?
Mitsubishi Tanabe Pharmaceuticalshave estimated that Radicava will be directly available to US patients in August 2017. In the meantime, US patients may also be able to import edaravone from Japan (as Radicut)by either filing a Single Patient Investigational New Drug (IND) request with the FDA, or by following the FDA’s Personal Importation Policy. (For more information please contact your physician, your local pharmacy or TheSocialMedwork at firstname.lastname@example.org or on + 31 + 208084414).
I don’t live in the US or Japan. How can I access edaravone?
Patients in Australia, Europe and the rest of the world may also be able to import edaravone (as Radicut) via their country’s personal importation scheme. For more information talk to your local pharmacy, GP, healthcare specialist or contact TheSocialMedwork.com.