Information about Radicava (Edaravone)

 

The FDA has approved Radicava™ (Edaravone), the first new treatment specifically for ALS in 22 years. The drug was approved by the FDA less than a year after Mitsubishi Tanabe Pharma Corporation submitted a New Drug Application. The only other approved treatment specifically for ALS, riluzole, was approved in 1995. Please click the links on the right to find more information on Radicava and check back often for updates.

Press Release

 

 



Frequently Asked Questions About Radicava™ (Edaravone)
(based on information as of 08/08/2017)


*The following is for informational purposes only and should not be taken as medical advice. People living with ALS should consult with their doctors for advice regarding Radicava or any other medical treatment. ALS Association chapters and staff should refer individuals to their healthcare providers for medical advice.

Where can I get the most up-to-date information about Radicava?
Patients should call Searchlight for the most up-to-date Radicava information.

Searchlight Support:
1-844-SRCHLGT (1-844-772-4548)
Monday-Friday, 8AM – 8PM ET
www.Searchlight.Radicava.com/hcp/

MT Pharma America
https://www.radicava.com/patient/

Go to www.Radicava.com to provide an email address, which will enable the patient to receive updates on availability from MTPA.

What is Radicava?
Radicava™ (edaravone) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat people with amyotrophic lateral sclerosis (ALS).1 In clinical trials, some people given Radicava showed significantly less decline in physical function compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in patients with ALS.1,2

What will Radicava do for people with ALS? How meaningful of a treatment is it?
Although Radicava is not a cure, it may be an important advance in helping people live with the disease. Because people with ALS experience varying rates of progression, slowing the decline of that loss of function is important. Depending on a person’s level of function when they begin treatment, the impact Radicava demonstrated in clinical trials could translate into potentially helping people preserve function longer.1

What is the recommended dose of Radicava?
Radicava is administered via intravenous infusion. According to the Prescribing Information, Radicava is administered in 28-day cycles by intravenous infusion. It takes 60 minutes to receive each 60 mg dose.1

For the initial cycle, the treatment is infused for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused for 10 days within a 14-day period, followed by a two-week drug-free period.1

What data formed the basis for the FDA approval?
Study MCI186-19 was the pivotal Phase 3 study that evaluated the efficacy and safety of Radicava compared with placebo in 137 people with ALS. In the study, after a 12-week pre-observation period, eligible patients were randomized 1:1 to receive Radicava 60 mg intravenously for 60 minutes or placebo during a six-month double-blind placebo-controlled phase. The primary endpoint for the study was change in the ALSFRS-R score from baseline to six months.1

Were there any issues with safety?
The most common adverse reactions that occurred in more than 10 percent of patients, and were greater than placebo, were bruising (contusion), trouble walking (gait disturbance), headache, inflammation of the skin (eczema) and rash (contact dermatitis).1

Hypersensitivity reactions1

  • Hypersensitivity reactions have occurred in patients receiving Radicava and can occur after administration.
  • Patients should be monitored carefully, since these reactions may occur. If hypersensitivity reactions occur, discontinue Radicava, receive treatment per standard of care, and monitor until symptoms and signs resolve. Notify your physician immediately.

Accessing Radicava Treatment

What company will be manufacturing and distributing Radicava?
Mitsubishi Tanabe Pharma America (MTPA), based in Jersey City, N.J., was established and is commercializing approved pharmaceutical products of Mitsubishi Tanabe Pharma Corporation (based in Osaka, Japan) in the U.S. market.

How can I get Radicava?
MTPA has outlined several steps you can take now to be able to access Radicava:

  • Like other FDA-approved medications, Radicava requires a prescription from your health care professional. Talk to him/her to determine if Radicava is an appropriate treatment for you. If it is, they will provide you with a prescription.
  • Go to www.Radicava.com to provide your email address, which will enable you to receive updates on availability from MTPA.
  • As soon as you receive a prescription, contact Searchlight Support by calling 844-SRCHLGT (844-772-4548). Searchlight Support can assist you with personal case management, reimbursement support, and once you start treatment, 24/7 product support. Some people with ALS who receive prescriptions for Radicava may be eligible to receive additional assistance from MTPA. MTPA will be able to discuss what assistance is available.

Why is Radicava not available immediately after FDA approval?
MTPA had to take multiple steps to accelerate importing Radicava to the U.S. There were certain portions of the complex supply chain that could not be done prior to approval. For example, FDA approval of the manufacturing facility and certain required customs clearances.

MTPA worked to import the medicine into the U.S. as quickly as possible. In addition to manufacturing hundreds of thousands of IV bags ahead of FDA approval, and taking steps to prepare logistics ahead of time, their plan is in place to air-ship Radicava to further accelerate the supply of the medicine from Japan, where it is manufactured.

How does the Searchlight Support program work?
Searchlight Support is a program developed by MTPA designed to help people with ALS, who have been prescribed Radicava, access the medicine and support people once they are taking the medicine. As soon as a patient receives a Radicava prescription and opts in to participate in the program, Searchlight Support will initiate:

  • Case Management: Every person who opts in will have access to a dedicated, personal case manager who will help them investigate and secure coverage through their insurance. The Case Manager will assist the person with ALS through the process.
  • Bridge Program: MTPA created a program in which eligible patients may receive Radicava at no charge from MTPA while their insurance is making a coverage determination. MTPA has established the eligibility requirements.
  • Clinical Educator Support: Under Searchlight Support, patients who sign up can ask a clinical educator questions about ALS, Radicava, or MTPA support programs. These clinical educators will be available to answer product or insurance-related questions day or night.

For more information, call 1-844-SRCHLGT or 1-844-772-4548. Patients prescribed Radicava should check eligibility requirements for each aspect of MTPA’s patient assistance program as restrictions apply.

How much will Radicava cost me?
The drug’s list price is $1K per infusion, $11K per dosage cycle, which amounts to $146K per year. This does not take into account coverage from insurance or Medicare/Medicaid. The company also says it will offer co-pay assistance for commercially insured patients. For more information please contact MT Pharma at www.mt-pharma-america.com or call at 844-772-4548.

What can I do if I don’t have insurance?
MTPA has created a program that provides Radicava at no charge if you do not have insurance and meet income and certain other requirements. The program is available to eligible patients without insurance. MTPA has established the eligibility requirements.

What happens while I’m waiting for Searchlight Support to confirm my insurance?
MTPA has developed a program in which eligible patients may receive Radicava at no charge from MTPA while insurance is making a coverage determination. MTPA has established the eligibility requirements.

Do I need to travel to an ALS Center?
Radicava is given to patients through an IV, and your insurance coverage may determine whether it is administered at an outpatient center, in your home, or another appropriate venue. MTPA will ship Radicava to approved centers for infusion and to specialty pharmacies that can deliver it to patients who will receive treatments in their homes.

What are my options for Radicava infusion sites?

  • Prescribing or non-prescribing physician’s office
  • Hospital outpatient department
  • Freestanding infusion center (independent infusion therapy provider, retail pharmacy with infusion services)
  • Home infusion/infusion provider (affiliation with a state-licensed pharmacy, hospital or nursing home)

How do I get infusion site location assistance?

  • Searchlight Support uses the MTPA National Infusion Center Directory to assist in finding infusion sites of care based on: proximity, insurance and hours of operation
  • Infusion sites of care can enroll in the Directory by visiting: www.mtsiteofcaredirectory.com/

Can Searchlight Support help with my transportation?
When you are first prescribed Radicava and opt in to Searchlight Support, your case manager can help you identify transportation options in your area.

What if I have clinical questions about Radicava?
Under Searchlight Support, patients who sign up can ask a clinical educator questions about ALS, Radicava, or MTPA support programs. These clinical educators will be available to answer product or insurance-related questions day or night.

Can I take Radicava while on Riluzole?
You should always check with your physician, but MT Pharma stated that 90% of the patients involved in its J-19 clinical trial were on Riluzole during the trial, and there is not a contra-indication.

What does “free radical scavenger” mean?
Radicava is designed as a “free radical scavenger” to help the body eliminate excess free radicals, thereby relieving the effects of oxidative stress thus preventing cell damage. See diagram below – RIGHT.

A free radical is an atom or molecule that is a toxic by-product of cells. They have unpaired electrons (see below) that make them highly unstable and reactive. Some normal functions of free radicals are important to cells, such as helping cells eliminate pathogens. However, when free radicals numbers rise too high, cell damage occurs harming the cell and its contents. This reactive cell damage caused by excess free radicals is called oxidative stress. See diagram – LEFT.

One way to combat cell damage caused by free radicals are antioxidants. They add the missing electron back to the free radical. This action stabilizes free radicals, turning them into normal “healthy” molecules, thus preventing cell damage caused by oxidative stress. See diagram – MIDDLE.

In ALS, it is thought that free radicals are not effectively removed, setting off an oxidative stress reaction. Oxidative stress is thought to damage motor neurons, the cells the die in ALS.

What does “RADICAVA caused a slowing in progression of functional loss in ALS patients” mean?
ALS patients saw an slowing in progress of functional disability while taking Radicava demonstrated by a higher score on the ALS Functional Rating Scale – Revised (ALSFRS-R) compared to people taking the placebo. This impact observed in trials could translate into potentially helping preserve a person’s function longer, such as feeding oneself or hugging a loved one. However, Radicava does not stop the underlying disease mechanism from occurring in motor neurons (the cells that die in ALS).



Click here for an infographic from MT Pharma about how they are expediting delivery of Radicava to the United States.

 


 
 

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