- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Application Submitted to FDA for First-Line Use of Tysabri (Natalizumab) in MS
Approval would expand drug’s indication (Jan. 16)
An application has been submitted to the FDA requesting an update to the labeling for Tysabri (natalizumab, Biogen Idec/Elan Corporation). The application requests an expanded indication that would include first-line use for patients with certain relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus (JCV). A formal assessment of the application is ongoing.
The submission is supported by risk-stratification data and a risk algorithm that enables physicians and patients 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 use of the drug early in the course of treatment, regardless of the level of disease activity or prior treatment history.
Because of an increased risk of an opportunistic viral infection (progressive multifocal leukoencephalopathy), Tysabri is generally recommended in the U.S. for patients with relapsing forms of MS whose disease is not responding to, or who are unable to tolerate, an alternative therapy regardless of JCV status.
Data from the phase III AFFIRM trial — published in the New England Journal of Medicine — showed that after 2 years, treatment with Tysabri led to a 68% relative reduction (P < 0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42% to 54% (P < 0.001).
Source: Biogen Idec; January 16, 2013.