Janssen collaborating International Union Against Tuberculosis and Lung Disease on Sirturo study

US health care giant Johnson & Johnson’s (NYSE: JNJ) Europe-based subsidiary, Janssen, is to collaborate with the International Union Against Tuberculosis and Lung Disease to include Sirturo (bedaquiline) in the STREAM study. STREAM is an ongoing multicenter international randomized control trial to evaluate a standard treatment regimen for patients with multidrug-resistant tuberculosis.

It is working with the Union and the study’s principal investigators from the UK Medical Research Council on an amendment to the current protocol to include two bedaquiline-containing treatment arms to assess safety and efficacy in adult patients with pulmonary multidrug-resistant tuberculosis, and to evaluate a new treatment regimen. This is the first ever injection-free regimen tested to date in this indication.

This is part of the post-approval requirements for bedaquiline from both the US Food and Drug Administration and the European Medicines Agency, and is accepted by both authorities as an alternative to the initially-planned Phase III trial of Sirturo.