FDA Approves New Medicine for Relapsing and Primary Progressive Forms of Multiple Sclerosis
March 28th, 2017
On March 28, the FDA approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis.
News in brief
- First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis (PPMS) – one of the most disabling forms of multiple sclerosis (MS).
- An important new treatment option for people with relapsing forms of multiple sclerosis (RMS) demonstrating superior efficacy on the three major markers of disease activity compared with Rebif®.
- A favorable benefit-risk profile demonstrated in three large Phase III studies with a diverse patient population, including those early in the disease.
Important Safety Information
OCREVUS can cause serious side effects, including:
- Infusion reactions: OCREVUS can cause infusion reactions that can be serious and require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
- itchy skin
- coughing or wheezing
- trouble breathing
- throat irritation or pain
- feeling faint
- redness on your face (flushing)
- swelling of the throat
- shortness of breath
- fast heart beat
These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.
If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
- OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Tell your healthcare provider if you 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 you have received your last dose of OCREVUS. If you have an active infection, your healthcare provider should delay your treatment with OCREVUS until your infection is gone.
- Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS treatment in clinical trials, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on 1 side of your body, strength, or using your arms or legs.
- Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have 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. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS.
- Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
Before receiving OCREVUS, tell your healthcare provider about all of your medical conditions, including if you:
- have ever taken, take, or plan to take medicines that affect your 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.
- You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with OCREVUS. You should not receive ‘live’ or ‘live attenuated’ vaccines while you are being treated with OCREVUS and until your healthcare provider tells you that your immune system is no longer weakened.
- When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with OCREVUS If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with OCREVUS, talk to your healthcare provider.
- If you are pregnant or planning to become pregnant talk to your doctor about vaccinations for your baby, as some precautions may be needed.
- are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm your unborn baby. You should use birth control (contraception) during treatment with OCREVUS and for 6 months after your last infusion of OCREVUS.
- are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS.
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 OCREVUS?
OCREVUS may cause serious side effects, including:
- Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information, go to www.OCREVUS.com or call 1-844-627-3887.
For additional safety information, please see the [accompanying] full Prescribing Information and Medication Guide.
"The FDA’s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy. Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine."