Introduction
This report details a case study for assessing the benefit-risk of natalizumab for the treatment of relapsing remitting multiple sclerosis (RRMS) versus placebo or alternative RRMS drugs interferon 𝛽-1a and glatiramer acetate.
This drug was approved in 2004 by the FDA. In 2005 the drug was suspended because of an associated incidence of progressive multifocal leukoencephalopathy (PML), a rare neurological disorder. In 2006 it was re-introduced due to patient demand, but with strict risk minimization measures. In 2011 the inclusion of anti-JC virus antibody status as a PML risk factor was included in the label of natalizumab.
Natalizumab has been used as the issue of a rare serious side effect in an effective treatment for a serious disease made for an interesting case study. Key questions to be addressed were as follows:- 1.Should natalizumab be given marketing approval at the time of first registration given the evidence of PML in clinical trials?
- 2.Should natalizumab be kept on the market given that increased episodes of PML were observed in the post-marketing setting?