Genentech Release: Highly Anticipated Multiple Sclerosis Medicine Offers New Hope

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Photo Courtesy of OCREVUS

MISSION, KS--(Marketwired - April 10, 2017) -

(Family Features) Multiple sclerosis (MS) is a chronic neurological disease for which there is no cure.(1) Affecting about 400,000 people in the U.S., MS can display an unpredictable mix of physical, cognitive or emotional symptoms that vary from person to person and can change over time.(2,3) In most people, the disease eventually leads to some level of disability.(3)

People are often diagnosed in the prime of their lives (20s-40s) when they may be building their careers or planning a family.(3) After being diagnosed in 2011 at 39 years old, Wayne Donovan, a Texas firefighter, knows firsthand what it’s like to live with the unpredictability of having a relapsing form of multiple sclerosis (RMS).

Numbness in his hand and foot prompted Wayne to see an orthopedist, thinking he had pinched a nerve. However, the doctor recognized that it may be something more serious and referred him to neurologist Dr. Edward Fox of Central Texas Neurology Consultants, who diagnosed him with RMS.

“By the time I saw Dr. Fox, about three quarters of my body was either numb and tingling or had pins and needles,” said Wayne. “As a firefighter, I have to be strong and present in tough situations -- I didn’t know what this meant for me and my family.”

MS occurs when the immune system attacks the insulation around nerve cells in the brain, spinal cord and/or optic nerves, causing inflammation and potentially debilitating symptoms.(3) The majority of people with MS have either, RMS, characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery; or primary progressive MS (PPMS), one of the most disabling forms of MS that until recently has had no FDA-approved treatment options.(4,5,6) People with RMS continue to experience disease activity and worsening disability.(7)

Dr. Fox had a discussion with Wayne about participating in a clinical trial that was investigating OCREVUS™ (ocrelizumab), a medicine that treats MS in a different way by targeting specific B cells in the immune system. After researching the trial, Wayne enrolled and eventually received OCREVUS. It is given every six months as an intravenous infusion.(8)

In March 2017, the U.S. Food and Drug Administration (FDA) approved OCREVUS as the first and only medicine for both relapsing and primary progressive forms of MS.(8)

“The FDA approval of OCREVUS is an exciting milestone for the MS community, especially for those with primary progressive MS, who for the first time have an FDA-approved treatment option,” said Dr. Fox. “As the first approved MS treatment to target B cells, this represents a scientific advancement in MS treatment. OCREVUS has a proven ability to slow the worsening of disability with a favorable benefit-risk profile demonstrated in three large Phase III studies.”

The studies showed that when compared to Rebif in people with RMS, OCREVUS reduced relapses by nearly half, was better at slowing disability progression and suppressed signs of disease activity in the brain over two years.(8)

In PPMS patients, OCREVUS also slowed disability progression and reduced signs of disease activity in the brain compared with placebo.(8)

The most common side effects associated with OCREVUS were upper respiratory tract infections and infusion reactions.(8)

“I have really good days and I have bad days,” said Wayne. “Though I got a skin rash from my first treatment, I haven’t had other side effects. Even though I think about my MS, I have not had a relapse since I’ve been on OCREVUS. I had a good experience in the clinical trial and liked that I was able to help researchers learn more about MS. Ultimately I am helping to bring medicines like OCREVUS to patients like me who need more treatment options.”

For more information about MS, visit the Multiple Sclerosis Association of America.

Indication

OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.

It is not known if OCREVUS is safe or effective in children.

IMPORTANT SAFETY INFORMATION

Who should not receive OCREVUS?
Do not receive OCREVUS if you are a patient that has an active hepatitis B virus (HBV) infection. Do not receive OCREVUS if you are a patient that has had a life threatening allergic reaction to OCREVUS. Patients should tell their healthcare provider if they have had an allergic reaction to OCREVUS or any of its ingredients in the past.

What is the most important information about OCREVUS?
OCREVUS can cause serious side effects, including:

• Infusion Reaction: OCREVUS can cause infusion reactions that can be serious and require a patient to be hospitalized. A patient will be monitored during the infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Patients should tell their healthcare provider or nurse if they get any of these symptoms: itchy skin, rash, hives, tiredness, coughing or wheezing, trouble breathing, throat irritation or pain, feeling faint, fever, redness on the face (flushing), nausea, headache, swelling of the throat, dizziness, shortness of breath, fatigue, or fast heart beat.

  These infusion reactions can happen for up to 24 hours after the infusion. It is important that patients call their healthcare provider right away if they get any of the signs or symptoms listed above after each infusion. If a patient gets infusion reactions, the healthcare provider may need to stop or slow down the rate of the infusion.

• Infection:
• OCREVUS increases a patient’s risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Patients should tell their healthcare provider if they have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after a patient has received their last dose of OCREVUS. If a patient has an active infection, their healthcare provider should delay treatment with OCREVUS until the infection is gone.
• Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS treatment, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe disability. Patients should tell their healthcare provider right away if they have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on one side of the body, strength, or using arms or legs.
• Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, a patient’s healthcare provider will do blood tests to check for hepatitis B viral infection. If a patient has ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. A healthcare provider will monitor a patient if they are at risk for hepatitis B virus reactivation during treatment and after they stop receiving OCREVUS.
• Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase a patient’s risk of getting infections.

Before receiving OCREVUS, patients should tell their healthcare provider about all of their medical conditions, including if they:

• have ever taken, take, or plan to take medicines that affect the immune system, or other treatments for MS.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have had a recent vaccination or are scheduled to receive any vaccinations. A patient should receive any required vaccines at least 6 weeks before they start treatment with OCREVUS. A patient should not receive certain vaccines (called ‘live’ or ‘live attenuated’ vaccines) while being treated with OCREVUS and until their healthcare provider tells them that their immune system is no longer weakened.
• are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm an unborn baby. Patients should use birth control (contraception) during treatment with OCREVUS and for 6 months after the last infusion of OCREVUS.
• are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into the breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if the patient takes OCREVUS.

What are possible side effects of OCREVUS?
OCREVUS may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer. Patients should follow their healthcare provider’s recommendations about standard screening guidelines for breast cancer.

Most common side effects include infusion reactions and infections.

These are not all the possible side effects of OCREVUS.

Patients should call their doctor for medical advice about side effects. Side effects may also be reported to the FDA at 1-800-FDA-1088.

For more information, go to OCREVUS.com or call 1-844-627-3887.

For additional safety information, please see the full Prescribing Information and Medication Guide.

All trademarks used or mentioned are protected by law. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.

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(1) MS International Federation. What is MS? Available at http://www.msif.org/about-ms/what-is-ms/.

(2) Tullman MJ. Overview of the epidemiology, diagnosis, and disease progression associated with multiple sclerosis. Am J Manag Care. 2013;19(suppl 2):S15-S20.

(3) National Institutes of Health-National Institute of Neurological Disorders and Stroke. (2015). Multiple Sclerosis: Hope Through Research. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research.

(4) Multiple Sclerosis International Federation. Types of MS. Available at https://www.msif.org/about-ms/types-of-ms/.

(5) National Multiple Sclerosis Society. Treating PPMS. Available at http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Primary-progressive-MS/Treating-Primary-Progressive-MS.

(6) National Multiple Sclerosis Society. Types of MS. Available at http://www.nationalmssociety.org/What-is-MS/Types-of-MS

(7) Gajofatto, A., & Benedetti, M. D. (2015). Treatment strategies for multiple sclerosis: When to start, when to change, when to stop?. World Journal of Clinical Cases. WJCC, 3(7):545-555.

(8) OCREVUS (ocrelizumab) Prescribing Information. Genentech, Inc. March 2017.