FDA Extends Review Process for Biogen's Multiple Sclerosis Drug, Plegridy

Biogen Idec Inc.'s newest multiple sclerosis drug, Plegridy, is undergoing an extended review process. The U.S. Food and Drug Administration made the announcement earlier today, which will delay the drug's mid-2014 release.

Biogen Idec Inc. was one of the world's first biotechnology companies and is currently a leader in research for unmet medical needs. With over 30 years of experience in the biotechnology industry, Biogen Idec has made countless contributions to advancements in medicine and patient care.

The company has released various multiple sclerosis drugs, including Avonex (Interferon Beta-1A), Tysabri (Natalizumab), Fampyra (Prolonged-Release Fampridine Tablets), and Tecfidera (Dimethyl Fumarate). These drugs have all passed phase 1, phase 2, phase 3, filing, and approval stages. Plegridy (Peginterferon Beta-1A) is currently in the approval stage, the final step of the process.

Plegridy is a chemically modified version of interferon beta-1a (Avonex) and is designed to increase half-life and systemic exposure of the protein administered through injection, as described on the Biogen Idec website. In other words, it would be prescribed to reduce the dosing schedule of other interferon drugs because they lead to flu-like symptoms, which causes patients to delay or refuse treatment.

Avonex is prescribed to slow the progression of disability and reduce relapses of multiple sclerosis. The disease affects the central nervous system and destroys the myelin sheath surrounding nerve cells in the brain, optic nerve, or spinal cord. Thus, the body begins to break down because it disrupts the flow of information between the brain and the body. The disease is three times more common in women than men, affecting 2.3 million people worldwide. The causes of MS are still unknown.

The FDA requested three months to further review Plegridy's application, which is likely to delay its mid-2014 release. The administration did not request further studies, so perhaps the approval process won't take longer than expected. To read more about the FDA's decision, visit this Wall Street Journal article as well as this Reuters article.