News

Otsuka Begins Paediatric MDR-TB Trials

Enrollment has begun for a ground-breaking clinical program exploring the use of delamanid in paediatric multidrug-resistant tuberculosis (MDR-TB). Otsuka is the first company to perform a trial among this population for regulatory approval. The programme will also evaluate the bioequivalence of a dispersible formulation for use with younger children and infants.

Childhood TB is a neglected segment of an already neglected disease. The WHO estimates that there are a half-million cases of childhood TB resulting in 64,000 deaths worldwide. In a recent report, the European Medicines Agency highlighted the success of paediatric regulation in spurring high-quality research, better information on the use of medicine in children and more age-appropriate formulations (www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500143984.pdf).

A recommendation on the use of delamanid in adult MDR-TB patients is expected later this month from the European Committee for Medicinal Products for Human Use. The compound is also under regulatory review in Japan and a Phase 3 trial in adult MDR-TB patients is already underway, including those with co-existing HIV infection.

For more information, contact richard.ferreira@hkstrategies.com.

For more information on delamanid go to http://www.newtbdrugs.org/project.php?id=136.

More News
30 Mar 2021
Médecins Sans Frontières (MSF) published a press release on World TB Day 2021 announcing their clinical trial, TB-Practecal , investigating novel treatment for MDR-TB has stopped enrolling earlier than originally planned due to promising results. The trial's independent data safety and monitoring...
3 Feb 2021
Last week, the World Health Organization (WHO) held a consultation to discuss the definition of extensively drug resistant (XDR) tuberculosis. The meeting was held to discuss novel treatment regimens and diagnostics for drug-resistant TB and determine its impact on the definition of XDR-TB. The...
10 Dec 2020
The Stop TB Partnership Working Group on New TB Vaccines (WGNV), Working Group on New TB Drugs (WGND), and New Diagnostics Working Group (NDWG) are developing an online course specifically designed for advocates and affected communities to provide a base of knowledge in TB research and to generate...