Biogen Idec Submits a New MS Treatment to FDA for Approval

UPDATE: On July 19, 2013, Biogen Idec announced that the United States Food and Drug Administration (FDA) had accepted their application for the marketing approval of Plegridy&#0153 in the United States. The FDA will review the drug under its standard review timeline. The European Medicines Agency (an agency in Europe similar to the FDA in the United States) is also reviewing an application for the approval of Plegridy in the European Union.

On May 21, 2013, Biogen Idec submitted a new treatment for multiple sclerosis (MS) to the United States Food and Drug Administration (FDA) for approval. This potential new disease-modifying therapy (DMT) for the long-term treatment of MS is a pegylated version of interferon beta-1a. Using the brand name of “Plegridy&#0153,” if approved, this new product would require fewer injections than the other presently approved self-injectable DMTs for MS.

Pegylation is a chemical modification of the interferon beta-1a molecule that extends its half-life, which refers to how long a drug stays active in the body before it is metabolized or eliminated. Given the longer half-life, Plegridy does not need to be taken as often as the presently approved self-injected DMTs for MS, which range from once daily to once weekly. This new medication has been studied in two groups – with injections given either every two weeks or every four weeks. Additionally, the 125-mcg dose is administered subcutaneously, which is easier and more comfortable for individuals who are self-injecting the medication, versus intramuscular injections.

Plegridy was submitted to the FDA based on the results from the first year of the two-year ADVANCE study. This Phase III clinical trial is an international multi-center study, which is placebo-controlled and double-blinded (so neither the patients nor the treating professionals know who is getting the active treatment). The 1,516 participants with relapsing-remitting MS (RRMS) were randomized to receive either the active drug or the placebo, given either once every two weeks or once every four weeks.

According to a press release from Biogen Idec, the data from the first year show that Plegridy met all of its primary and secondary endpoints by “significantly reducing disease activity including relapses, disability progression and brain lesions, compared to placebo, and showed favorable safety and tolerability profiles at one year.” After the first year, study participants who were taking the placebo were re-randomized to one of the two treatment groups (taking the active drug either once every two weeks or once every four weeks), and will continue on their new treatment for the remainder of the second year in the study. Once the study is completed, participants will be given the option to enroll in the ATTAIN open-label (no longer blinded) extensions study. Participants will be followed for up to four years in this second study.

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Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer