Priority Medicines for Europe and the World 2013 Update. Background Paper 6 - Priority Diseases and Reasons for Inclusion. BP 6.08 - Tuberculosis
(2013; 59 pages)

Abstract

The 2004 Priority Medicines Report stated that "Tuberculosis (TB) is a major and growing threat to public health for Europe and the world, with new epidemiological challenges." Global trends since then show that tuberculosis (TB) incidence, prevalence, and mortality rates are gradually declining. However the increase in multi-drug resistant (MDR)- and extensive drug resistant (XDR)-TB cases is worrisome. Tuberculosis remains a disease of poverty with a high burden of disease in the low and middle income countries (LMICs) and in countries with high HIV incidence. Within the European Union (EU)/ European Economic Area (EEA) the incidence rates of drug-sensitive and drug-resistant TB are declining in most countries.

Overall, the existing TB tools are not sufficient to eradicate tuberculosis. A substantial number of new diagnostics tools, including the Xpert MTB/RIF assay, have been endorsed by the WHO-STAG, but none of these tests are suitable for use in a point-of-care setting in the LMICs. The current treatment regimens are lengthy, have a high pill burden, require commitment from the patient, and can have severe side effects. There is currently only one vaccine available for prevention of TB, however, its protective effects are highly variable. New TB tools are needed and must be suitable for all forms of TB in people of all ages, including the HIV-positive population and children. These tools must deliver quick results and be suitable for use in the LMICs.

Since the 2004 report one novel pharmaceutical (bedaquiline) has obtained market authorization by the United States regulatory authority (FDA). Bedaquiline is also under evaluation by the EU regulatory authority (EMA). A second novel pharmaceutical (delamanid) has applied for market authorization with the EMA. There are several compounds in phase II, but the early clinical pipeline is empty. In contrast, the field of diagnostics has seen many changes since 2004. The Xpert MTB/RIF assay rollout has changed the face of TB diagnosis in several countries, most importantly South-Africa. The diagnostics pipeline is relatively full and looks promising. Another promising research area is the development of vaccines. The current pipeline shows there are 16 vaccines in clinical trials. Vaccines for prevention of TB are only in phase II of development. In general product development partnerships (PDPs) and public-private partnerships (PPPs) have played a crucial role in the development of these promising pipelines of new TB tools...

Considerable progress has occurred since 2004 in the development of new treatments, diagnostics, and vaccines, often with EC support. Continued and increased support from the EC is required and needs to be a long-term commitment.

 
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