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FDA Approves Oral Vumerity™ (Diroximel Fumarate), Similar to Tecfidera®, for Relapsing MS

October 30, 2019

Updated 11/17/19 with cost information
SUMMARY
  • The U.S. Food and Drug Administration has approved Vumerity™ (diroximel fumarate, Biogen and Alkermes plc) as an oral disease-modifying therapy for people with relapsing forms of MS.
  • Relapsing forms of MS  includes people with clinically isolated syndrome (an initial episode of neurological symptoms), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
  • Vumerity is similar to dimethyl fumarate (Tecfidera,® Biogen) but has a distinct chemical structure that has been shown to have fewer reported gastrointestinal side effects than Tecfidera.
  • This approval provides another treatment option for people living with relapsing forms of MS and specifically includes people with secondary progressive MS who are continuing to experience active disease.
 
“We are pleased that there is a new oral treatment option for people with relapsing MS,” said Kathy Costello, MS, ANP-BC, MSCN, Associate Vice President of Healthcare Access at the National MS Society.
 
Download the Medication Guide for patients (.pdf)
Download prescribing information (.pdf)

DETAILS

The U.S. Food and Drug Administration has approved Vumerity™ (diroximel fumarate, Biogen and Alkermes plc) as a disease-modifying therapy for people with relapsing forms of MS, including clinically isolated syndrome (an initial neurological episode), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
 
About Vumerity: Multiple sclerosis involves immune system attacks that cause inflammation and damage in the brain and spinal cord tissues. Vumerity is similar to Tecfidera but has a distinct chemical structure that has been shown to be better tolerated, with fewer reported gastrointestinal side effects than Tecfidera. Once in the body, Vumerity rapidly converts to the same active ingredient as Tecfidera. Because of the bio-equivalence to Tecfidera, it was not necessary for Vumerity to undergo extensive clinical trials to demonstrate benefits for relapsing MS. Although their exact mechanisms of action are not known, Vumerity and Tecfidera are thought to modulate the immune response to be less inflammatory and may have antioxidant properties that could be protective against damage to the brain and spinal cord.
 
Potential benefits: Biogen Inc. and Alkermes plc announced top-line results of a five-week, Phase III study that compared gastrointestinal side effects and tolerability of Vumerity and Tecfidera. According to a press release, diroximel fumarate was better tolerated and had significantly fewer reported gastrointestinal symptoms compared to Tecfidera. The most common adverse events for both treatment groups were flushing, diarrhea and nausea. Rates of these events were significantly lower for the diroximel fumarate group, and fewer people on diroximel fumarate dropped out of the study due to side effects.
 
The approval of Vumerity is based largely on the FDA’s findings of safety and efficacy for Tecfidera. Twice-daily Tecfidera was shown in clinical trials to significantly reduce relapses and disease activity on MRIs, and in one trial it reduced progression of disability. The Tecfidera approval was based on results of two large-scale phase III studies, called DEFINE and CONFIRM, which were conducted in people with relapsing-remitting MS. The results were published in 2012.
 
Potential Risks: Like Tecfidera, Vumerity may cause serious side effects including: allergic reaction (such as welts, hives, or difficulty breathing); PML (progressive multifocal leukoencephalopathy - a rare brain infection that can lead to death or severe disability over a period of weeks or months); decreases in white blood cell count, and liver problems.
 
The most common side effects of Vumerity include: flushing, redness, itching, or rash; nausea, vomiting, diarrhea, stomach pain, or indigestion. Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking Vumerity with food (avoid high-fat, high-calorie meal or snack) may help reduce flushing. The Prescribing Information (.pdf) provides full information on potential side effects.
 
Pre-dosing Tests and Evaluations: 
  • Before starting treatment, the FDA recommends that a person’s health care provider assess a recent (within 6 months) blood cell count, and repeat the blood cell count every 6 to 12 months thereafter.
  • Providers should test liver function before starting treatment, and during treatment if clinically indicated.
  • Vumerity is not recommended for people with moderate to severe impairment of kidney function.
  • Before treatment with Vumerity, women should talk to their health care providers if they are pregnant or planning to become pregnant. There are no adequate data on the developmental risk associated with the use of Vumerity in pregnant women.
 
Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
 
For more information about support services provided by Biogen, people can contact the company’s Above MS program at www.AboveMS.com. 
 
Download the Medication Guide for patients (.pdf)
Download prescribing information (.pdf)
Read more about disease-modifying therapies and other treatments for MS and MS symptoms.
 
Tecfidera is a registered trademark of Biogen.
Vumerity is a trademark of Alkermes Pharma Ireland Limited used by Biogen under an exclusive license.

 

FAQ About FDA’s Approval of Oral Diroximel Fumarate – Brand name Vumerity™ – for Relapsing MS

 
Q. What types of MS is Vumerity approved to treat?
A. The FDA has approved Vumerity for the treatment of relapsing forms of MS, including clinically isolated syndrome (an initial neurological episode), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity. 

Q. How is Vumerity taken?
A. The capsules are taken orally twice per day. When Vumerity is begun, individuals will be provided with a one-week starter dose, and thereafter a maintenance dose, both taken twice daily. 

Q. What are the potential side effects of Vumerity?
A. Vumerity may cause serious side effects including: allergic reaction (such as welts, hives, or difficulty breathing); PML (progressive multifocal leukoencephalopathy -- a rare brain infection that usually leads to death or severe disability over a period of weeks or months); decreases in white blood cell count, and liver problems. The most common side effects of Vumerity include flushing, redness, itching, or rash; nausea, vomiting, diarrhea, stomach pain, or indigestion. Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking Vumerity with food (avoid high-fat, high-calorie meal or snack) may help reduce flushing. The Prescribing Information (.pdf) provides full information on potential side effects. 

Q. Why should a person with MS consider taking a disease-modifying therapy?
A. Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Studies comparing people in clinical trials who started therapy earlier than those on inactive placebo suggest that early treatment offered important benefits against the accumulation of disability, which were generally not experienced to the same degree by those who started treatment later. 

Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors. 

Q. Should I switch from my current therapy to Vumerity?
A. The decision about whether to take Vumerity should be made in collaboration with your MS doctor, taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors. Important questions to be considered and discussed with your doctor in terms of Vumerity include:
  • How am I doing on my current therapy?
  • What is my tolerance for the risk of known side effects?
  • What is my tolerance for the risk of adverse consequences that might emerge with longer-term use?
  • How will my medication choice affect my ability or plans to become pregnant?
  • What are the comparative costs of my current therapy versus Vumerity? 
Q. How long would a person take Vumerity?
A. There is no specified time limit for taking Vumerity.

Q. Are there any risk factors or medical conditions that would make it inappropriate for an individual to take Vumerity?
A. Vumerity is not recommended for people with moderate to severe impairment of kidney function. Before treatment with Vumerity, women should talk to their health care providers if they are pregnant or planning to become pregnant. There are no adequate data on the developmental risk associated with the use of Vumerity in pregnant women.

Q. Will a person taking Vumerity have to get any special medical tests or monitoring?
A. Before starting treatment, the FDA recommends that a person’s health care provider assess a recent (within 6 months) blood cell count, and repeat the blood cell count every 6 to 12 months thereafter. Providers should test liver function before starting treatment and during treatment if needed. 

Q. What will Vumerity cost?
A. The yearly cost of Vumerity was announced to be $88,000 wholesale acquisition cost (WAC). The actual cost to an individual who has MS will depend on the provisions of his or her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.

Q. What is the Society's view of the cost of Vumerity?
A. “Vumerity is an efficacious and tolerable treatment option for people with relapsing MS, but being priced only $500 lower than the least expensive oral disease modifying treatment, does not show the commitment to affordable access that we had hoped,” said Bari Talente, Executive Vice President, Advocacy, National MS Society. 
“We know that high wholesale acquisition cost (WAC) prices for MS disease modifying treatments put a heavy burden on people with MS. Too many are forced to take on high out-of-pocket costs, navigate through complex systems, and face varied and unpredictable decisions by public and private payers and pharmacy benefit managers.
 
Q. Will my health insurance cover Vumerity?
A. Coverage will depend on individual insurance plans.
 
Q. Is there a generic form of Vumerity?
A. No. 

Q. Where can I get information about the patient support that Biogen plans to provide?
A. For more information about support services provided by Biogen, people can contact the company’s Above MS program at www.AboveMS.com. 

Q. Is Vumerity being tested in primary progressive MS or non-active secondary-progressive MS?
A. Not at this time.
 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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