WHO launches Target Regimen Profiles for TB treatment
The new profiles seek to guide the drug/regimen development process, enabling important drug and regimen features to respond to the needs of end-users, care providers and policymakers.
07 September 2016 - GENEVA: The World Health Organization (WHO) launched a new Target Regimen Profiles for TB treatment, at the European Respiratory Society (ERS) Annual Congress in London, on Sunday, 4 September.
Aimed at the pharmaceutical industry, research institutions,
product development partnerships and donors, the new profiles
seek to guide the drug/regimen development process, enabling
important drug and regimen features to respond to the needs of
end-users, care providers and policymakers.
“These
profiles, which go beyond the current standard of care,
represent ideal product attributes and priorities to be
considered early and coherently during the TB drug research and
development process. The goal of candidate regimens must be to
be more effective, less toxic, shorter and less-burdening on
patients and health systems, ” said Dr Mario Raviglione,
Director of the WHO Global TB Programme.
The
profiles were developed in consultation with a wide range of
stakeholders including national TB programmes, civil society,
partners, regulatory authorities and drug developers. The
process was led by the WHO Task Force on New TB Drug Policy
Development.
The quest for shorter, affordable, safe and effective anti-TB regimens
Despite progress in drug development, current regimens present
several challenges to achieving cure, such as limited efficacy
and tolerability of drugs for MDR-TB treatment, drug-drug
interactions causing safety problems, complexity of treatment
protocols for drug-sensitive and drug-resistant TB, and cost
concerns. Furthermore, the conventional drug development process
is slow. The time is nearly doubled in length by the need for
further clinical testing of regimens after constituent drugs
have received regulatory approval.
“Setting
clear, attainable attributes for future TB treatment regimens
– and even for those already in experimental phases
of development - is crucial for accelerating release of
effective TB regimens, rapid regulatory approval and uptake by
countries. Target regimen profiles offer this novel opportunity
to all drug developers and researchers,” said Dr Christian
Lienhardt, Team Leader Research for TB Elimination at the WHO
Global TB Programme.
Prioritizing the needs of patients
The target regimen profiles outline characteristics aimed to
address needs of patients, such as pill burden, duration of
treatment, toxicity and invasive drug safety monitoring. In
addition, the profiles address barriers in rolling out new drugs
and regimens.
Representatives of the
stakeholders involved in the process expressed their support for
the immediate use of these profiles. Mr Wim Vandevelde, Civil
Society Representative from the European AIDS Treatment Group
(EATG) and Global Tuberculosis Community Advisory Board (TB
CAB), emphasised, “Our ultimate goal in the TB community
is to decrease suffering and save lives. This can only be
possible if we ensure that the design of TB regimens is
patient-centric, thus tackling the root of the problem we face
in getting patients to cure.”
Dr Giovanni
Battista Migliori, ERS Secretary-General and Director, WHO
Collaborating Centre for TB and Lung Diseases in Italy, added,
“While the landscape of TB drug development has evolved
dramatically in recent decades, one major obstacle continues to
be the length of time to find optimal drug combinations and also
the time to obtain regulatory approvals for new products. These
target regimen profiles support regimen development rather than
individual drug development. These profiles have the potential
to cause a paradigm shift by urging drug developers to direct
their efforts towards identifying optimal drug combinations from
the very beginning of the TB drug R&D process.”
The way forward
Following the launch of the profiles, WHO and its Task Force on
New TB Drug Policy Development will monitor their use,
collecting feedback and working with developers, end users and
patients to make them more useful, and revising them to reflect
new developments in TB treatment and diagnosis.
“The
benefit of widely accepted target regimen profiles is clear.
Such profiles serve to clarify what attributes of novel regimens
will add value in the fight to end TB” said Dr Mel
Spigelman, CEO of the TB Alliance, one of the stakeholders
engaged in the development of improved, simpler, safer, and
affordable TB treatments.
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