News

Soleo Health Named a Limited Drug Distribution Partner by Mitsubishi Tanabe Pharma America for RADICAVA ORS®

Company Named as a Specialty Pharmacy to Distribute Newly FDA-Approved Oral Suspension Treatment for Amyotrophic Lateral Sclerosis (ALS)

FRISCO, Texas, June 7, 2022 - Soleo Health, an innovative leader and national provider of complex specialty pharmacy services, announced today it was named one of only four limited distribution drug (LDD) specialty pharmacy partners to dispense nationwide RADICAVA ORS® (edaravone) oral suspension, commercialized by Mitsubishi Tanabe Pharma America, Inc. (MTPA), which commercializes approved pharmaceutical products in North America.

The Food & Drug Administration (FDA) approved the oral formulation of edaravone on May 12, 2022. RADICAVA ORS is among a select few FDA-approved oral treatments for patients with Amyotrophic Lateral Sclerosis (ALS), a neurodegenerative disorder. Edaravone is also approved in an intravenous (IV) formulation, known as RADICAVA® (edaravone).

Soleo Health’s dedicated ALS Therapeutic Care Management Center (TCMC) will clinically manage patients who are prescribed RADICAVA ORS. Soleo Health has provided RADICAVA since its launch in 2017. Each new ALS patient under Soleo Health’s care is assigned a Soleo Health patient ambassador who can help address any questions. The distinctive Soleo Health ALS TCMC is also staffed with specially trained interdisciplinary teams comprising highly experienced therapy-care pharmacists, registered nurses, and reimbursement and patient care specialists.

According to Johns Hopkins Medicine, ALS affects as many as 30,000 people in the U.S., with 5,000 new cases diagnosed each year. It weakens muscles over time while impacting physical function and ultimately leading to death.

“Soleo Health’s five-year partnership with MTPA for delivering infused RADICAVA, along with our dedication to the ALS community, will continue with the successful introduction of RADICAVA ORS. Our team continues to demonstrate value in providing therapy and care for infused RADICAVA patients, which will afford those patients a smooth, seamless transition to RADICAVA ORS, should they and their prescriber make this treatment decision. Prescribing physicians can also take comfort in our related expertise and ability to manage their ALS patients, regardless of route of administration,” explained Drew Walk, Soleo Health chief executive officer.

“We look forward to continuing our partnership with Soleo Health, which is one of the specialty pharmacies that has the specific knowledge and experience to best support the ALS community, and also shares our unwavering dedication to helping patients,” said Atsushi Fujimoto, President, MTPA.

About Soleo Health

Soleo Health is an innovative national provider of complex specialty pharmacy services administered in the home or at alternate sites of care. Soleo Health’s interdisciplinary clinical team comprises highly experienced pharmacists, registered nurses, reimbursement specialists and patient care ambassadors. The Company optimizes patient access solutions and delivers comprehensive services, leading to quantifiable clinical and economic value, resulting in positive patient experiences.

Soleo Health operates 21 locations throughout the U.S. with national nursing coverage and pharmacy licensure in 50 states and is accredited by URAC, ACHC with Distinction in Rare Disease and Orphan Drugs and The Joint Commission.

Visit www.soleohealth.com or connect with Soleo Health on LinkedIn, Facebook and Twitter for more information.

About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone)

The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA is administered in 28-day cycles by IV infusion. It takes 60 minutes to receive each 60 mg dose. 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. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS is taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc (MTDA), commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, RADICAVA was approved for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), China (July 2019), Indonesia (July 2020), Thailand (April 2021) and Malaysia (December 2021). To date, in the U.S., RADICAVA has been used to treat over 6,500 patients, with nearly one-million days of therapy, and has been prescribed by more than 1,600 HCPs.

IMPORTANT SAFETY INFORMATION

Do not receive RADICAVA ORS (edaravone) if you are allergic to edaravone or any of the ingredients in RADICAVA ORS.

Before you take RADICAVA ORS, tell your healthcare provider about all of your medical conditions, including if you:

  • have asthma.
  • are allergic to other medicines.
  • are pregnant or plan to become pregnant. It is not known if RADICAVA ORS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if RADICAVA ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA ORS or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of RADICAVA ORS?

RADICAVA ORS may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions.

  • Hypersensitivity reactions have happened in people receiving RADICAVA or taking RADICAVA ORS and can happen after your medicine has been given.
  • RADICAVA ORS contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
  • Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).

Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions.

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

These are not all the possible side effects of RADICAVA ORS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch or Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058.

INDICATION

RADICAVA ORS is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

For more information, including full Prescribing Information and Patient Information, please visit WWW.RADICAVAORS.COM

RADICAVA and RADICAVA ORS are registered trademarks of Mitsubishi Tanabe Pharma America, Inc.