FDA Approves New Interferon Beta Drug for Multiple Sclerosis
Plegridy™ reduces relapses, disability progression and brain lesions, studies show.
The U.S. Food and Drug Administration (FDA) has approved Plegridy™ (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). Clinical trials show the drug reduces relapses, disability progression and brain lesions.
“The MS community always welcomes the expansion of treatment options that may alter the course of MS,” said Ben Thrower, M.D., medical director of the Andrew C. Carlos MS Institute at Shepherd Center in Atlanta. “Plegridy is in the class of interferon beta therapies. Other options in this class include Betaseron, Extavia, Rebif and Avonex. This class of drugs has been shown to reduce the frequency of relapses, slow progression of disability and help prevent new lesions on MRI.
“As a group, interferon beta therapies have a proven record of long-term safety, as well,” Dr. Thrower added. “Plegridy will be given on an every-two-week basis by subcutaneous injection and may be appealing to some as it is the least frequently dosed medication of its type.”
The drug, marketed by Biogen Idec, can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.
“Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class and significantly fewer injections than other beta interferon treatments,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Plegridy represents the most significant innovation in the interferon class in more than a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.”
The FDA approval of Plegridy is based on results from one of the largest pivotal studies of beta interferon. The study, called ADVANCE, involved more than 1,500 people with MS. It was a two-year, Phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety of Plegridy administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received Plegridy for the duration of the study.
In the first year of the clinical trial, researchers found that Plegridy dosed once every two weeks significantly reduced the annualized relapse rate at one year by 36 percent compared to placebo. Plegridy reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 38 percent compared to placebo. Plegridy also significantly reduced the number of new gadolinium-enhancing lesions by 86 percent and reduced new or newly enlarging T2-hyperintense lesions by 67 percent compared to placebo.
The most common adverse reactions were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching and joint pain. The ADVANCE two-year safety data were consistent with safety results observed in year one.
Plegridy was also recently approved by the European Commission.
“It is always encouraging to have additional treatment options that may help people with MS manage their disease as we move toward our ultimate goal of ending MS forever,” said Timothy Coetzee, Ph.D., chief advocacy, services and research officer at the National MS Society.
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Shepherd Center provides world-class clinical care, research, and family support for people experiencing the most complex conditions, including spinal cord and brain injuries, multi-trauma, traumatic amputations, stroke, multiple sclerosis, and pain. An elite center recognized as both Spinal Cord Injury and Traumatic Brain Injury Model Systems, Shepherd Center is ranked by U.S. News as one of the nation’s top hospitals for rehabilitation. Shepherd Center treats thousands of patients annually with unmatched expertise and unwavering compassion to help them begin again.