Mitsubishi Tanabe Pharma America has announced that Radicava, its intravenous therapy for adults with ALS, is now available in the United States.

Approved by the U.S. Food and Drug Administration (FDA) on May 5, 2017, Radicava is the first ALS treatment to gain FDA approval in more than 20 years.

Although Radicava is not a cure, it may be an important advance in helping people live with the disease. In a clinical trial, the drug was shown to slow the decline in loss of physical function by 33 percent as compared to placebo.

While people with ALS experience varying rates of progression, the loss of physical abilities can be fast, so slowing the decline of that loss of function in ALS is incredibly important. Depending on the level of function when someone begins treatment, the impact Radicava demonstrated in clinical trials could translate into potentially helping people preserve function longer, enabling them, for example, to get out of bed or feed themselves without assistance.

Accessing Radicava

Access to Radicava is initiated by an individual’s health care provider and facilitated through the Searchlight Support hub, which provides assistance for people who are prescribed Radicava.

The first step to accessing Radicava is to get a prescription for the drug, so be sure to talk with your physician if you think treatment with Radicava may be right for you. As soon as you receive a prescription, contact Searchlight Support at 844-772-4548.

A Searchlight Support care coordinator can help identify an infusion service site based on your geographic location. Once the benefits investigation is completed, a case manager will contact you to explain benefits and co-pay support options.

Treatment regimen

Radicava is given to patients through an IV and can be administered at several different types of locations, depending on each individual’s health plan and physician recommendation.

• ALS center
• physician’s office
• free-standing infusion center
• hospital outpatient department
• home infusion provider

Radicava is administered in 28-day cycles. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period.

It takes 60 minutes to receive each 60 mg dose.

The most common side effects of Radicava include bruising, problems walking (gait disturbance) and headache.

Radicava may relieve oxidative stress

Radicava is thought to work by relieving the effects of oxidative stress, which has been suspected to play a role in the death of nerve cells called motor neurons in people with ALS. (Oxidative stress is an imbalance between the production of free radicals and the ability of the body to counteract or detoxify their harmful effects with antioxidants.)

Targeting this pathway could potentially preserve motor neuron health, which could in turn, keep muscles functional for a longer period of time.

Find out more

For additional information on Radicava, see What is Radicava (Edaravone)?.