Biogen Idec and Elan Corporation have submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the Tysabri (natalizumab) labels. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus (JCV).

A formal assessment of both applications is ongoing.

These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with Tysabri. If approved, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider Tysabriearly in the course of treatment, regardless of the level of disease activity or prior treatment history. Tysabri is a highly efficacious treatment that has been shown to slow disability progression by 42 – 54 per cent and reduce annualized relapse rates by 68 per cent.

“Our anti-JCV antibody test, STRATIFY JCV, helps to determine the most appropriate patients for Tysabriand the data collected to date supports our recent filing for first-line use,” said Alfred Sandrock, MD, Ph.D., senior vice president, Development Sciences and chief medical officer, Biogen Idec. “Many appropriate patients are already benefiting from Tysabri. A first line approval would allow people with MS access to a highly efficacious treatment earlier in the course of the disease, potentially leading to better outcomes. This is an important consideration for people with MS who may want or need more efficacy.”

Currently in the US, due to an increased risk of an opportunistic viral infection, progressive multifocal leukoencephalopathy (PML), Tysabri is generally recommended for people living with relapsing forms of MS whose disease is not responding to, or who are unable to tolerate, an alternative therapy regardless of JCV status. In the EU, Tysabri is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferons or have rapidly evolving, severe RRMS.

“Tysabri is an important treatment option for thousands of people living with MS,” said Hans Peter Hasler, chief operating officer, Elan Corporation, plc. “We are excited about these filings and the potential to make Tysabriavailable as a treatment option for more individuals early in the course of their disease.”

Tysabri is approved in more than 65 countries. Tysabri is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferons or have rapidly evolving, severe RRMS.

Tysabri has advanced the treatment of MS with its established efficacy. Data from the phase III AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, Tysabri treatment led to a 68 per cent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 per cent (p<0.001).

Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are the presence of anti-JCV antibodies, prior immunosuppressant use, and longer Tysabri treatment duration. Patients who have all three risk factors have the highest risk of developing PML. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. A list of adverse events can be found in the full Tysabri product labeling for each country where it is approved.

Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapies for serious diseases with a focus on neurology, immunology and haemophilia.

Elan Corporation, plc is a neuroscience-focused biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world.