FDA Extends PDUFA Date For Biogen's Plegridy For Multiple Sclerosis
By Cyndi Root
Biogen Idec announced in a press release that the Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Plegridy review. The Biologics License Application (BLA) has been extended a standard amount of time, three months, and the FDA has not asked for further clinical studies. Plegridy is indicated for relapsing multiple sclerosis. Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development, said, “We believe that based on the efficacy and safety that Plegridy has demonstrated, in addition to its less frequent dosing schedule, it has the potential to become a preferred interferon treatment option.”
Relapsing Multiple Sclerosis
In multiple sclerosis, a person’s body betrays him or her. Attacks on myelin, nerve fiber protection, leads to damaged nerve fibers (axons). Relapsing multiple sclerosis (RMS) is a difficult condition to live with as the disease progression varies. Some people avoid serious symptoms, while others suffer immediate disabilities. Over 80% of people diagnosed with MS face mild or severe flare-ups, attacks, or relapses. Symptoms include balance problems, cognitive deficits, visual problems, and loss of bladder or bowel control. Relapses average one to two per year. Treating acute relapses quickly helps the patient live a quality life.
Plegridy
Plegridy is a novel agent, a new molecular entity, in the interferon class of treatments. It works by pegylating interferon beta-1a, prolonging exposure times in the body. Pegylation, also known as PEGylation, is a modification of a peptide or non-peptide molecule or a protein by linking polyethylene glycol (PEG) chains. PEG-drugs reside in the body longer, degrade less easily, and reduce protein immunogenicity.
Biogen Idec’s application for a Biologics License Application (BLA) was based on a two-year global Phase III ADVANCE study. Study results showed that Plegridy met primary and secondary endpoints. Patients experienced fewer relapses, fewer brain lesions, and reduced disease progression compared to the placebo group. Additionally, at one year, the medication was well tolerated and deemed safe.
About Biogen Idec
Biogen Idec is headquartered in Weston, Massachusetts and has offices in Canada, Europe, and Japan. The company markets its pharmaceuticals in over 60 countries. It focuses on treatments for neurodegenerative diseases, hemophilia, and autoimmune disorders.