Johnson & Johnson has been a committed partner in the global fight against TB for more than two decades. We are currently working to help end TB through our comprehensive 10-year initiative announced in 2018, and our public promise to invest $500 million in the development and delivery of innovations to combat TB and also HIV. We work closely with governments and other partners in high-burden, low- and middle-income countries to build critical health systems capacity and capabilities by training health workers, improving diagnosis, raising awareness and reducing stigma around TB in local communities. We have also taken numerous steps to ensure appropriate use and stewardship of bedaquiline in line with the World Health Organization guidelines to prevent the development of resistance to the medicine. See section on Overcoming Antimicrobial Resistance.
As part of this effort, we donated 105,000 courses of treatment, free of cost, to 80 countries through a four-year donation program (2015 – 2019), operated in partnership with the U.S. Agency for International Development (USAID) and JSC Pharmstandard.
In total, between 2012 and 2019, we delivered 188,000 courses of bedaquiline to patients in 138 countries.
Expanding treatment for TB and DR-TB patients
Bedaquiline is a core component of WHO-recommended treatment: In 2019, the World Health Organization (WHO) published a Rapid Communication indicating that all-oral regimens containing Johnson & Johnson’s bedaquiline are the preferred treatment options for all patients with multidrugresistant tuberculosis (MDR-TB) and rifampicin-resistant TB (RR-TB). This decision expands the use of bedaquiline in shorter treatment regimens to replace injectable agents. WHO advised national TB programs to phase out the use of injectable-containing short-course regimens, which have been known to cause toxic side effects for patients. The Rapid Communication was released in advance of updated consolidated drug-resistant tuberculosis (DR-TB) treatment guidelines, expected in 2020, to help national TB programs to begin planning for a rapid transition to what WHO describes as “more effective, less toxic and easier to implement” regimens.
The decision from WHO reiterates the importance and value of bedaquiline as a vital component of modernized DR-TB treatment regimens.
Expanding treatment to young people: In 2019, we secured U.S. Food and Drug Administration (FDA) approval for bedaquiline tablets as part of combination therapy for eligible MDR-TB patients aged 12 years and over in the United States. This FDA approval marks the first regulatory milestone as part of Johnson & Johnson’s global pediatric R&D program for bedaquiline. Additionally, our new pediatric formulation of bedaquiline for children aged 5 to < 12 years of age is under review at the FDA and European Medicines Agency. For those children under 12 years of age, a 20 mg tablet was developed, which can be dispersed in water to make it easier for children to swallow. These developments represent a significant advance for children suffering from hard-to-treat forms of TB. Furthermore, we are striving to achieve even more with our pediatric program: a clinical study is ongoing to evaluate the pediatric formulation of our medicine among children aged 2 to 4, and once preliminary data is available, the youngest age cohort (0 – 2 years of age) will begin enrollment.
New report shows cost-benefit of treating DR-TB
While the cost of inaction is high, the EIU report highlights that addressing DR-TB provides good value for the investment. The benefit-to-cost ratio for investing in diagnosis and treatment of DR-TB specifically has been estimated at up to US$23 for every dollar invested.
Read the EIU report: "It’s Time to End Drug- Resistant Tuberculosis: The Case for Action.”
Activities to accelerate an end to TB in India
In 2019, we announced the expansion of our TB program in India through a series of new collaborations with multilateral and non-governmental organizations (NGOs), as well as the Government of India, to support India’s efforts to end TB by 2025, as outlined in its National Strategic Plan for TB Elimination. For the past four years, Johnson & Johnson has worked with the Government of India to scale up access to bedaquiline, providing 22,000 courses free of charge, as part of a donation program administered by USAID. Our expanded TB program in India includes:
- Using "edutainment" and visual campaigns to reach patients and break stigma: With our support, the MTV Staying Alive Foundation launched a new edutainment radio campaign, MTV Nishedh (meaning "taboo" in Hindi), on a popular radio station across six cities in India to raise awareness about critical health issues, including TB, and help young people make more informed choices about their health. We also partnered to launch a Metro Awareness project in Hyderabad to increase awareness of TB through visual campaigns in 45 metro trains.
- Partnering to enhance diagnostic capacity: We are supporting a new effort through which the Foundation for Innovative New Diagnostics (FIND) will provide technical assistance to establish new TB culture and drug-susceptibility testing facilities in at least seven sites across India with a focus on three high-burden states.
- Training health workers to improve standards of care: We launched a unique collaboration with the International Union Against Tuberculosis and Lung Disease to help build capacity of public-sector healthcare providers for the effective management of TB and DR-TB. We will support capacity building workshops for clinicians and healthcare workers in seven high-burden states. Also, we invested in further efforts to improve care for DR-TB patients with plans to train an additional 5,000 healthcare professionals by the end of 2020.
- Strengthening private-public treatment pathways: We are supporting a pilot initiative with TB Alert India to expand referrals of patients from the private to the public health system. The model involves a dedicated call center and an online platform, CONNECT FOR LIFE, developed by Johnson & Johnson to help track and support patients throughout their treatment.
Collaborating to eradicate TB
New research consortium: In 2019, we launched an international research consortium to discover and develop new TB antibiotics in collaboration with eight European academic and biotechnology partners. Co-funded with Europe’s Innovative Medicines Initiative (IMI), this initiative, called RESPIRI-TB, is one of several partnerships we are advancing at Johnson & Johnson to accelerate TB R&D. The RESPIRI-TB initiative will help enable the development of a new, more efficient combination drug regimen to cure MDR-TB, while shortening treatment duration and minimizing the likelihood of resistance. The new consortium includes nine research teams spanning five European countries, and the RESPIRI-TB program also supports a pillar of Europe’s IMI AMR Accelerator Programme.