Biogen Idec drugs show promise for multiple sclerosis

Kathleen Blanchard's picture
Biogen Idec injectable MS drug shows promise for preventing relapses.

Study results presented at the American Academy of Neurology's 2013 annual meeting show an injectable drug from Biogen Idec Inc could cut relapse for multiples sclerosis patients up to 36 percent. The drug, Peginterferon beta-1a is not yet approved, but if it is, the MS drug will be marketed under the brand name Plegridy. The drug is currently under patent with Biogen until 2028.

The drug, when compared to placebo, substantially reduced MS disease activity, progression of brain lesions and disability and relapses at one year, meeting primary endpoints of the Phase III trial. Plegridy reduces brain lesions associated with MS that occur from destruction of the sheath that line nerve fibers in the brain by 86 percent - known as gadolinium-enhancing lesions

Patients were studied for two years for the trial and were randomized to receive 125 mcg of the drug administered subcutaneously every two weeks or every four weeks or placebo.

Included were 1,516 patients with relapsing-remitting multiple sclerosis or RRMS, which is the most common form of the neurological disease that is progressive and thought to be from autoimmune dysfunction.

The drug works by extending the half-life of interferon beta-1a to boost immune function. Unlike other first-line interferon treatments for the disease, the drug would require less frequent dosing.

In the trial, the drug was administered either once every 2 or every 4 weeks, with both dosing schedules being effective. Every 2 week doses was found to be superior for preventing relapse.

Peter Calabresi, director of the Johns Hopkins Multiple Sclerosis Center said, "These full first-year results provide a more complete picture of Plegridy and its positive effects on the reduction of relapse, disability progression and lesion development. These data suggest that, if approved, Plegridy may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS,”, reports RTT news.

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Other Biogen MS drug in the pipeline

In addition to Plegridy, Biogen Idec is planning another MS drug that is anticipated to be a leading multiple sclerosis treatment that can be taken in pill form. The drug, Tecfidera is currently under review in the U.S., European Union, Australia, Canada and Switzerland and has been tested in two large Phase III clinical trials.

According to Biogen, Tecfidera (dimethyl fumarate) given twice or three times a day was also compared to placebo, meeting a “number of critical endpoints compared to placebo at two years per the DEFINE and CONFIRM TRIALS. The drug displayed ‘favorable’ safety and tolerability.

A current Phase III extension study, ENDORSE is ongoing that includes 1700 patients; designed to ensure long-term safety and to find out if the drug could be used as a singular effective treatment for MS. The ENDORSE study is anticipated to be completed in 2016.

The drug lowered multiple sclerosis relapses by 53 percent in the DEFINE trial and reduced disability progression by 38 percent.

In the CONFIRM trial researchers compared the drug that reduces inflammation to Copaxone and placebo. Relapse rates were reduced by 44 percent and Copaxone 29 percent compared to placebo.

The Biogen drugs Plegridy and Tecfidera could offer new hope for multiple sclerosis treatment, pending regulatory approval. The FDA will decide on approval of Tecfidera for treatment of MS next week.

Image credit: Wikimedia Commons

AAN annual meeting, 2013