“This is a real game changer.” – Cyndi Zagieboylo, President and CEO, National MS Society

SUMMARY

  • The U.S. Food and Drug Administration has approved Ocrevus™ (ocrelizumab – Genentech, a member of the Roche Group) for the treatment of primary progressive MS or relapsing MS, based on clinical trials showing significant benefits against MS relapses and progression.
  • This is the first therapy specifically approved to treat primary progressive MS.
  • Potential safety issues identified by the FDA include infusion reactions and infections. There may be an increased risk of malignancy in people taking Ocrevus.
  • Ocrevus is taken by IV infusion every six months.
  • More information about Ocrevus is available from Genentech:  1-844-OCREVUS (9am-8pm Eastern)

DETAILS

The U.S. Food and Drug Administration has approved Ocrevus™ (ocrelizumab – Genentech, a member of the Roche Group) for use in the treatment of primary progressive MS and relapsing MS, making it the first therapy for the treatment of primary progressive multiple sclerosis. Ocrevus will be available as a first-line treatment, which means that there are no recommendations in the approved labeling for people to try other MS therapies before taking it. Ocrevus has not been tested in children.

Comments
“As the first therapy specifically approved to treat primary progressive MS, this represents a significant milestone,” said Kathy Costello, MS, ANP-BC, MSCN, Associate Vice President of Healthcare Access at the National MS Society.

“We are grateful that there is finally a disease-modifying treatment for people with primary progressive MS, and also an important new option for people with relapsing MS,” said Bruce Bebo, PhD, Executive Vice President, Research, at the National MS Society. “We hope this is just the first of many new treatments approved for people with progressive MS.”

About Ocrevus
Ocrevus is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells, and reduces the numbers of certain B cells that are circulating in the blood. B cells have several functions including making antibodies, and they are believed to play a role in immune-system-mediated damage to brain and spinal cord tissues in MS. Ocrelizumab is administered by intravenous infusion every 6 months. The first dose is given in two infusions, two weeks apart. Subsequent doses are given as a single infusion.

Potential Benefits
Primary Progressive MS: The ORATORIO study involving people with primary progressive MS, which compared Ocrevus to inactive placebo, met its primary endpoint, showing treatment with Ocrevus significantly reduced the risk of progression of clinical disability by 24% compared with placebo in 732 people. Compared to placebo, Ocrevus also reduced the time required to walk 25 feet by 29%, and decreased the volume of brain lesions.

Relapsing MS: In the OPERA I and OPERA II studies involving people with relapsing MS, which compared ocrelizumab to interferon beta-1a (Rebif,® EMD Serono and Pfizer), Ocrevus significantly reduced the annualized relapse rate by up to 47% compared with Rebif over two years in a total of 1,656 people with relapsing MS. In addition, Ocrevus significantly delayed confirmed progression of disability on the EDSS scale by 40% compared with Rebif. Ocrevus also significantly reduced active inflammation observed on MRI scans by up to 95%, and total damage on MRI scans by up to 83% compared with Rebif.

Potential Risks
Prescribing information and the Medication Guide (.pdf) for Ocrevus includes several warnings and precautions.

  • Ocrevus can cause a wide variety of infusion-related reactions, the most frequent being itchy skin, rash, irritation in the throat, flushed face or fever, headache or other symptoms. In rare cases, these can be life-threatening. Infusion reactions occur most frequently with the first infusion, and they can occur up to 24 hours after the infusion. As a precaution, people are administered a steroid and antihistamine before their infusion and monitored at least one hour after infusion.
  • Ocrevus increases the risk of infection, including respiratory tract infections and herpes infections. Ocrevus administration should be delayed in people with an active infection, and vaccination with live or live-attenuated vaccines is not recommended during treatment and not until B cells have been repopulated following treatment.
  • There may be an increased risk of malignancy (cancers), including breast cancer, in people taking Ocrevus. Individuals using Ocrevus should follow standard breast cancer screening guidelines.The clinical trial results and ongoing monitoring of trial participants indicate an imbalance in the number of cancers that occurred in individuals treated with Ocrevus compared to those who were on interferon in the relapsing remitting trial and those on placebo in the primary progressive trial.The numbers are too small to know for sure if this is related directly to Ocrevus. This imbalance will require continued careful observation, evaluation, and data in larger numbers of individuals.
  • PML: Although no cases of PML (progressive multifocal leukoencephalopathy), a serious brain infection, occurred in clinical trials, PML has been observed in people taking related medications for other conditions. Typical symptoms are diverse, progress over days to weeks and include progressive weakness on one side of the body or clumsiness, vision disturbances, and changes in thinking, memory, orientation and personality.
  • Hepatitis B Virus Reactivation: Although no cases of hepatitis B virus reactivation have been reported in people taking Ocrevus, they have occurred in people taking similar medications. Before initiating treatment with Ocrevus, individuals should have a blood test to detect hepatitis B virus.

For more information, people with MS can contact Genentech at: 1-844-OCREVUS (9am-8pm Eastern)

For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions: (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.

Comment on Pricing
The approval of Ocrevus is an exciting milestone for people with primary progressive MS and an encouraging new option for people with relapsing forms of the disease. The National MS Society applauds Genentech for their leadership in setting the wholesale acquisition cost (or list price) of Ocrevus at $65,000 per year — nearly 20 percent below the current market average for an MS treatment. The continually escalating prices of MS disease-modifying therapies are creating barriers to people with MS getting these life-changing medications. Through its action on Ocrevus, Genentech is changing industry dynamics so that more people can access the life-changing treatments they need to live their best lives. We encourage other companies to follow suit, creating a drug pricing trend that keeps patients first.

Resources
Read the press release from the FDA
Download the prescribing information
-Read details of the clinical trials of Ocrevus in two papers published in the December 21, 2016 issue of the New England Journal of Medicine:
“Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis”
(Dr. Xavier Montalban and others)
“Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis”
(Dr. Stephen Hauser and others)

Ocrevus is a trademark of Genentech, a member of the Roche Group.
Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.


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