BioCentury
ARTICLE | Clinical News

Tysabri natalizumab regulatory update

May 18, 2015 7:00 AM UTC

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began its review to evaluate whether advice given to healthcare professionals regarding the risk of progressive leukoencephalopathy (PML) with Biogen’s Tysabri natalizumab should be revised. The PRAC will evaluate available data to assess whether the methods used to calculate risk of PML need to be revised and whether PML testing in patients with no symptoms should be performed more frequently. ...