Regulatory Focus™ > News Articles > New Multiple Sclerosis Treatment Wins FDA Approval, Clearing Way for Likely Blockbuster Status

New Multiple Sclerosis Treatment Wins FDA Approval, Clearing Way for Likely Blockbuster Status

Posted 28 March 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has granted approval to Biogen Idec's new multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate capsules), clearing the way for the company to market what some analysts have called a likely blockbuster.

The drug is one of several now approved to treat MS, an autoimmune disease of the central nervous system. Other drugs include Novartis' Gilenya, Sanofi's Aubagio, and  Biogen Idec's Tysarbi and Avonex.

In a statement, FDA regulators said that, like all other existing drugs, Tecfidera doesn't fully cure MS.

"No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients," said Russell Katz, director of the Division of Neurology Products in FDA's Center for Drug Evaluation and Research (CDER). "Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person's quality of life."

But the drug's real advantage comes from its relative safety. Other drugs, such as Tysarbi, contain strong warnings, such as an increased risk of developing a potentially fatal brain infection known as progressive multifocal leukocephalopathy (PML).

The approval notice for Tecfidera mentions no major restrictions such as those found under a Risk Evaluation and Mitigation Strategies (REMS) plan, though the drug was associated with a potential decrease of a patient's white blood cell count, which could potentially raise the risk of infection. FDA said it recommended patients have their white blood cell count tested before starting treatment and every year thereafter.


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