The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) failed to recommend marketing approval for delamanid, a new drug in development for multidrug-resistant tuberculosis (MDR-TB). A letter from the Treatment Action Group criticizing this decision is included.
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.
This week, efficacy data from the recently completed Phase 2 randomized placebo-controlled trial in MDR patients evaluating delamanid with background treatment compared to placebo with background treatment was published yesterday in the New England Journal of Medicine. Delamanid (OPC-67683) is a new agent derived from the nitro-dihydro-imidazooxazole class of compounds that inhibits mycolic acid synthesis. The abstract and overview of news coverage are presented, as well as, additional links to TB R&D news.
On September 16, the 4th International Workshop on Clinical Pharmacology of Tuberculosis Drugs was held adjacent to the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) which was held from September 17 to 19. Between the two meetings, there were many updates related to TB drug development. Additional links to TB R&D are included.