FDA Approves Plegridy (Pegylated Interferon Beta) For Relapsing MS - National Multiple Sclerosis Society

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FDA Approves Plegridy (Pegylated Interferon Beta) For Relapsing MS

August 15, 2014

The U.S. Food and Drug Administration has approved Plegridy™ (peginterferon beta-1a, Biogen Idec) as a new disease-modifying therapy for people with relapsing forms of MS. Peginterferon beta-1a, injected under the skin every two weeks, is a new therapy that belongs to the same interferon class as several medications that have been approved to treat MS. This new version is designed to maintain the effects of interferon in the body for a longer period of time. Read more details about this medication.

“This new medication combines the benefits of a therapy with a long track record of successful use in MS and a well-established safety profile, with the option of a less frequent injection schedule which may prove more convenient for people with MS,” commented Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University’s Feinberg School of Medicine, and Chair of the National MS Society’s National Medical Advisory Committee.

“It is encouraging to have additional treatment options that may help people with MS manage their disease as we move towards our ultimate goal of ending MS forever,” noted Timothy Coetzee, PhD, Chief Advocacy, Services, and Research Officer at the National MS Society.

Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and disease progression. Selecting an MS therapy should be done by people with MS in collaboration with their MS doctors, 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.

About Plegridy: Peginterferon beta-1a is a new therapy that belongs to the same interferon class as several medications that have been approved by the FDA for the treatment of people with relapsing forms of MS. Peginterferon beta-1a is a “pegylated” form of interferon, meaning that polyethylene glycol is attached to the interferon molecules, which enables them to maintain biologic effects in the body for longer periods of time and allows for less frequent dosing. Plegridy is given by subcutaneous (under the skin) injections once every two weeks.

Potential benefits: Plegridy was shown after one year of a two-year phase III clinical trial to reduce the relapse rate significantly more than placebo in a study of 1500 people with relapsing MS, reaching the primary goal of the study. (Lancet Neurology, published online, April 30, 2014.)

[For the “ADVANCE” trial, investigators worldwide randomly assigned 1512 people with relapsing MS to one of three groups: placebo, peginterferon beta-1a 125 mg delivered subcutaneously (under the skin) every two weeks, or peginterferon beta-1a 125 mg delivered subcutaneously every four weeks. The primary objective of the study was to determine the effects of the drug versus placebo on the annualized relapse rate after 48 weeks. Secondary objectives included the effects on central nervous system damage as observed on MRI scans, and disease progression as measured by the EDSS disability scale.

After the first year, participants on placebo were re-assigned to receive peginterferon every two or four weeks, and those already on therapy remained in their respective groups.

Results for the first year of the study showed that the annualized relapse rate was reduced significantly more than placebo, by 35.6% in the two-week dosing group, and by 27.5% in the four-week dosing group. New lesions (areas of tissue damage) on MRI scans were reduced by 67% in the two-week dosing group and by 28% in the four-week dosing group. The risk of disability progression (confirmed over 12 weeks), as measured by the EDSS scale, was reduced by 38% in both peginterferon groups.]

In this study peginterferon was not compared to other interferon medications, or other MS therapies, and so the results cannot be directly compared to those of other interferons or other MS therapies.

Potential risks and screenings: Safety and adverse events appeared to be consistent with other forms of interferon. The most common adverse reactions are injection site reactions, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, and joint pain. Most adverse events were of mild or moderate severity. A greater proportion of participants taking peginterferon had increased liver enzymes compared with those in the placebo group, but these did not result in discontinuation of treatment.

Before taking PLEGRIDY, tell your healthcare provider if you:

• Are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior
• Have or had liver problems, low blood cell counts, bleeding problems, heart problems, seizures (epilepsy), thyroid problems, or any kind of autoimmune disease
• Take prescription and over-the-counter medicines, vitamins, and herbal supplements
• Are pregnant or plan to become pregnant.  It is not known if Plegridy will harm your unborn baby.  Tell your healthcare provider if you become pregnant during your treatment with Plegridy
• Are breastfeeding or plan to breastfeed.  It is not known if Plegridy passes into your breast milk.  Talk to you healthcare provider about the best way to feed your baby if you use Plegridy.

More information:

Read more details about this medication
Download a medication guide from the FDA
Download the Prescribing Information (.pdf)

For more information about support services provided by Biogen Idec, people can contact the company’s MS ActiveSource® Program. MS ActiveSource is available by phone at 1-800-456-2255 or on the Web at www.MSActiveSource.com.

Read more about disease-modifying therapies and other treatments for MS and MS symptoms.


Avonex  is a registered trademark of Biogen Idec
Plegridy is a trademark of Biogen Idec
ActiveSource is a registered trademark of Biogen Idec


FAQ About FDA’s Approval of Peginterferon Beta-1a 
– Brand name Plegridy™ – for Relapsing MS

Q. What is Plegridy?
A.
Peginterferon beta-1a is a new therapy that belongs to the same interferon class as several medications that have been approved by the FDA for the treatment of people with relapsing forms of MS. Peginterferon beta-1a is a “pegylated” form of interferon, meaning that polyethylene glycol is attached to the interferon molecules, which enables them to maintain biologic effects in the body for longer periods of time and allows for less frequent dosing. Plegridy is given by subcutaneous (under the skin) injections once every two weeks. 

Q. Does Plegridy have the same effectiveness as other interferons?
A.
Based on the clinical trial conducted for the approval of Plegridy, we don’t know since in this study peginterferon was not compared to other interferon medications, or other MS therapies. However, during the first year of the trial relapse rates were reduced by 35.6% compared to those on placebo, which is in a similar range seen in the original studies conducted of other interferons.

Q. What types of MS is Plegridy approved to treat?
A.
The FDA has approved Plegridy for the treatment of patients with relapsing forms of MS. In other words, people who experience periodic MS attacks, such as those who have relapsing-remitting MS or secondary-progressive MS with relapses.

Q. How is Plegridy taken?
A.
Plegridy is taken by injection under the skin every two weeks. The dose should be titrated, starting with 63 micrograms on day 1, 94 micrograms on day 15, and 125 micrograms (full dose) on day 29.

Q. When will Plegridy be available by prescription?
A.
Plegridy is now available.  Read more details about this medication.

Q. How effective is Plegridy?
A.
Results for the first year of the clinical trial showed that the annualized relapse rate was reduced by 35.6% compared to those taking placebo. New lesions (areas of tissue damage) on MRI scans were reduced by 67%, and the risk of disability progression (confirmed over 12 weeks), as measured by the EDSS scale, was reduced by 38%.

Q. What are the potential side effects of Plegridy?
A.
The most common adverse reactions are injection site reactions, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, and joint pain.

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 doctors, 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 Plegridy?
A.
The decision about whether to take Plegridy 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 Plegridy 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 Plegridy?

Q. How does the effectiveness of Plegridy compare to other available therapies?
A.
We don’t have sufficient information to answer this question, based on the clinical trial conducted for the approval of Plegridy. In that trial, Plegridy was not compared to other interferon medications, or other MS therapies.

Q. How long would a person take Plegridy?
A. 
There is no specified time limit for taking Plegridy.

Q. Are there any risk factors or medical conditions that would make it inappropriate for an individual to take Plegridy?
A.
Plegridy should not be taken if an individual has a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of the formulation.

Plegridy is rated as a Pregancy Category C. There are no adequate and well-controlled studies in pregnant women. Plegridy should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Q. Will a person taking Plegridy have to get any special medical tests or monitoring?
A. 
 Yes. Because Plegridy can affect liver functions, people taking this medication should see their healthcare providers and have regular blood tests to check for possible side effects. 

Q. What will Plegridy cost?
A.
The price has not been announced, but 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. Will my health insurance cover Plegridy?
A.
Coverage will depend on individual insurance plans.

Q. Is there a generic form of Plegridy?
A.
No. 

Q. Where can I get information about the patient support that Biogen Idec plans to provide?
A.
For more information about support services provided by Biogen Idec, people can contact the company’s MS ActiveSource® Program. MS ActiveSource is available by phone at 1-800-456-2255 or on the Web at www.MSActiveSource.com.

Q. What other disease-modifying therapies are available for MS?
A.
There are nearly a dozen disease-modifying therapies available for people with relapsing forms of MS. These include therapies that are taken by mouth, injection, and infusion. Additional therapies are under development. Read more about ongoing clinical trials in MS. 

Q. I’ve been hearing news about other new treatments in development for MS. What are some details?
A.
Just a few of many approaches being explored include potential benefits of the hormone estriol, adult stem cell transplantation, large-scale clinical trials for progressive MS, trials of agents aimed at protecting the nervous system, and studies of vitamin D. Read more about ongoing clinical trials in MS.  In addition, the Progressive MS Alliance is a global effort to speed research and treatments on progressive MS.

There is a possibility that one or more generic forms of Copaxone® will become available in 2014, which may give more people with MS access to this disease-modifying treatment approach. Genzyme has stated that it will re-apply for FDA approval of the experimental therapy alemtuzumab for relapsing MS in 2014. This is given by a cycle of IV infusions once per year. In addition, other oral and infrequent-dose disease-modifying therapies are in clinical trials. These are just a few of many exciting research avenues that address ways to stop MS progression, restore function and end MS forever.

Q. Is Plegridy being tested in progressive MS?
A.
Not at this time.

Q. Why aren’t there more treatments for progressive MS?
A.
Nearly every therapy approved for relapsing MS has been tested, or is now in testing, in people with progressive forms of the disease, including primary-progressive MS and secondary-progressive MS. Up to now, clinical trials involving people with relapsing MS often rely on counting relapses or doing MRI scans to detect immune activity. The fact that there is no easy way to detect progression quickly is one reason why development of therapies for progressive MS is behind. The National MS Society is investing in better ways to detect benefits of therapies for progressive forms of MS. Right now there are large clinical trials going on in progressive MS, including tests of Tysabri,® Gilenya,® Ocrelizumab, Masitinib and Siponimod. Download a table of trials on focusing on progressive MS (.pdf).

Avonex is a registered trademark of Biogen Idec
Copaxone is a registered trademark of Teva Pharmaceutical Industries
Gilenya is a registered trademark of Novartis
MS ActiveSource is a registered trademark of Biogen Idec
Plegridy is a trademark of Biogen Idec
Tysabri is a registered trademark of Biogen Idec and Elan Pharmaceuticals
 

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts 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 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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