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An initiative to extend access to a new TB drug

28 April 2015

At the WHO GLI/GDI Partners Forum in Geneva, Otsuka announced its “FighTBack Initiative” to enable access to a new drug for the management of MDR-TB patients. The plan is centred around a “20 by 2020” goal, which is to ensure delamanid, Otsuka’s lead compound for multidrug-resistant MDR-TB, reaches 20% of all diagnosed and treated patients in quality programmes by 2020. On top of its ongoing compassionate use and expanded access programmes, Otsuka intends to incorporate a targeted access donation program, innovative research and development of new products for MDR-TB, optimized patient management, and collaborative capacity building, including working with communities using new approaches to ensure delamanid is administered safely and responsibly to minimize the threat of drug-resistance. Otsuka is working with other partners in developing collaborations to take forward this plan to meet its access goals, and more details on the collaborations will be made available in the coming months.   The company expects at least half of the 27 highest-burden MDR-TB countries will be among the initial recipients of delamanid.  WHO issued interim guidance on the use of delamanid in the treatment of MDR-TB in 2014.

Otsuka, which is progressing with clinical trials for a paediatric formulation of delamanid, concluded by calling on the TB community to increase the development and availability of paediatric formulations for other MDR-TB medicines, help increase access for new TB drugs through advocacy for regulatory harmonization, and work together to strengthen pharmacovigilance systems for improved data collection and safety monitoring.   
On acknowledging this new plan from Otsuka, Dr Mario Raviglione, Director of the Global TB Programme, said, "I wish we had more companies like Otsuka and Janssen Therapeutics* which have had the courage and the strong will, against many odds, to develop new drugs against TB and MDR-TB.  We need many more companies interested in pursuing research for new drugs and other innovations to allow our ambitious End TB targets to be reached in the next two decades".  
*On 1 April, USAID announced its launching of a bedaquiline donation program, made possible through an agreement with Janssen Therapeutics.  The program provides access to another novel drug for use in the treatment of MDR-TB, bedaquiline. WHO issued interim guidance on the use of bedaquiline in the treatment of MDR-TB in 2013.


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