FDA Approval of Bedaquiline — The Benefit–Risk Balance for Drug-Resistant Tuberculosis |
New England Journal of Medicine Skip to main content The New England Journal of Medicine …

Abstract Background In 2012, the Food and Drug Administration approved use of
bedaquiline fumarate as part of combination therapy for multidrug-resistant tuberculosis …

Tuberculosis (TB) is now the biggest infectious disease killer worldwide. Although the
estimated incidence of TB has marginally declined over several years, it is out of control in …

The US Food and Drug Administration (FDA) on 28 December 2012 granted accelerated
approval to Johnson and Johnson's drug bedaquiline to treat resistant tuberculosis (TB) …

The treatment of multidrug-resistant (MDR) or extensively drug-resistant (XDR) tuberculosis
(TB) remains a challenge for clinicians for several reasons, including the large number of …

Background Addition of bedaquiline to treatment for multidrug-resistant tuberculosis was
associated with an increased risk of death in a phase 2b clinical trial, resulting in caution …

Bedaquiline is a diarylquinoline antitubercular drug with a novel mechanism of action
against M ycobacterium tuberculosis. Bedaquiline works by inhibiting bacterial adenosine …

Multidrug-resistant (MDR) tuberculosis (TB) is a threat to global TB control, as suboptimal
and poorly tolerated treatment options have resulted in largely unfavourable outcomes for …

The world-wide increase in the incidence of multidrug-resistant tuberculosis (MDR-TB) and
extensively drug-resistant tuberculosis (XDR-TB) poses a major clinical challenge. The …

The emergence of multidrug-resistant tuberculosis (MDR-TB; defined as resistance to at
least rifampicin and isoniazid) represents a growing threat to public health and economic …