Otsuka FighTBack Initiative

Program Objectives

The priorities of the FighTBack initiative are to expand access to and ensure responsible use of delamanid, as well as to continue R&D efforts into novel MDR-TB treatment options, including diagnostic and treatment monitoring tools. The overall objective is that by 2020, at least 20% of diagnosed and treated MDR-TB patients should have delamanid as part of their treatment regimen through high quality programs.

Rational use of the MDR-TB compound delamanid is critical to ensuring that the greatest number of patients have access to this medicine over the longest period of time. Rational use of the MDR-TB compound delamanid is critical to ensuring that the greatest number of patients have access to this medicine over the longest period of time. Copyright Otsuka

What are the health needs and challenges?

Considering the dramatic rise in bacterial resistance worldwide, rational use of the MDR-TB compound delamanid is critical to ensuring that the greatest number of patients have access to this medicine over the longest period of time.

Description of partnership activities and how they address needs and challenges

Otsuka launched a FighTBack initiative which has 4 parts:

1. Innovative Research and Development;

2. Responsible Access to Patients;

3. Optimized Patient Management;

4. Collaborative Capacity Building.

As part of the FighTBack initiative, Otsuka is participating in a number of collaborative studies. One of them is the endTB project led by Médecins Sans Frontières (MSF), Partners in Health (PIH), and Interactive Research & Development (IRD). The endTB project will evaluate new regimens for the treatment of MDR-TB and reduce existing country-level barriers to the uptake of new TB drugs. Another study is called "MDR-END" led by the Seoul National University Hospital, looking at regimens that could shorten MDR-TB treatment. In December 2015 Otsuka provided a one-time donation of 400 treatment courses of delamanid to MSF for the endTB project in order to provide rapid access to patients in urgent need.

A key component of the initiative is also Otsuka's partnership with Stop TB Partnership's Global Drug Facility announced in February 2016, which enables about 100 eligible low- and middle-income countries to procure delamanid.  The Global Drug Facility is the largest procurer of quality-assured tuberculosis medicines and provides TB drug management technical assistance in an effort to promote equitable access to TB medicines and diagnostics.

Corresponding principle in the declaration

“As part of the WHO Global Action Plan’s proposal for a comprehensive program of sanitation, hygiene, vaccination, infection control, education, and stewardship, we support mechanisms to ensure affordable access to new and existing antibiotics to the patients who need them, in all parts of the world and at all levels of income. “

Read full Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance (AMR)


Partnership information

Company(ies) Otsuka

Therapeutic Focus Infectious Diseases

Disease(s) Drug-Resistant Infections (AMR)

Program Type(s) Research & Development - Innovative Funding Mechanisms, Research & Development - Operations Research

Region(s) World

Number of Countries 1

Country(ies) Worldwide

Research Country(ies) Worldwide

Start Date 2015

More information News release WHO

Anticipated completion date Ongoing