FDA has approved peginterferon beta-1a (Plegridy, Biogen Idec) for the treatment of adults with relapsing forms of multiple sclerosis (MS).
Multiple sclerosis is a chronic disease that attacks the central nervous system, made up of the brain, spinal cord and optic nerves. Symptoms vary from person to person and can range from numbness in the limbs to paralysis or loss of vision. It is estimated that there are currently more than 400,000 people diagnosed with MS in the United States.
Plegridy is a pegylated version of interferon beta-1a, a protein produced by the human body. Pegylation is a scientific process that increases the size of the molecule thereby prolonging its circulation time and extending the drug’s half-life which allows for less-frequent dosing. Increasing the size of the molecule also improves its solubility and shields the drug from enzymes that try to break it into smaller pieces. Plegridy suppresses the expression of inflammatory proteins in the central nervous system that are believed to be the major factors responsible for the autoimmune reaction that leads to multiple sclerosis.
Plegridy is administered subcutaneously once every 2 weeks and is available as a new ready-to-use autoinjector or prefilled syringe. The recommended dose of Plegridy is 125 μg every 14 days. Treatment starts with 63 μg on day 1. On day 15, the dose is increased to 94 μg, reaching the full dose of 125 μg on day 29.
"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," George A. Scangos, PhD, chief executive officer of Biogen Idec, said in a company news release.
The FDA approval of Plegridy is based on the ADVANCE trial, one of the largest studies of beta interferon ever conducted. ADVANCE was a 2-year study involving more than 1,500 participants to evaluate the safety and efficacy of Plegridy for the treatment of patients with relapsing multiple sclerosis. The results of the trial showed that Plegridy significantly reduced the annual relapse rate by 36% as well as reduced the risk for 12-week confirmed disability progression and the number of brain lesions compared to placebo.
The most common adverse reactions associated with the use of Plegridy include injection-site reaction, flu-like illness, fever, headache, muscle pain, weakness and joint pain. Depression and suicide have been observed in interferon beta therapy. Severe hepatic injury has also been reported in patients receiving Plegridy and caution should be used in patients with hepatitis, hepatic disease, jaundice, or alcoholism.
Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland