E-DRUG: MSF welcomes WHO guidelines on TB drug bedaquiline; but more work needed
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http://www.msfaccess.org/content/msf-welcomes-who-guidelines-tb-drug-bedaquiline-more-work-needed
The World Health Organization has this morning issued interim guidance on
the use of bedaquiline, the first new drug to treat tuberculosis in 50
years, which received accelerated approval by the US Food and Drug
Administration (USFDA) on 31 December 2012. Acknowledging the growing
crisis of multidrug-resistant TB (MDR-TB) and the urgent need for improved
drugs with better efficacy and safety profiles, WHO has taken an
unprecedented step to make interim recommendations about a drug based on
phase IIb clinical trial data. Given the risk-benefit considerations for
many people living with MDR-TB, MSF welcomes this move to accelerate
improved treatment to those who need it most.
The scale of the DR-TB epidemic is huge, with 310,000 new cases notified in
2011. But globally, only 19% of people thought to be infected are receiving
some kind of treatment. It is hoped that bedaquiline - which has shown in
trials to be potentially very effective against Mycobacterium tuberculosis,
the bacteria that causes - could become a powerful tool in much-needed
treatment regimens that are significantly shorter, more effective and less
toxic than current regimens. Treatment today for DR-TB involves a two-year
course of up to 20 pills per day and eight months of daily injections,
which cause patients excruciating side effects and ultimately cures only
one in two.
In 2012, Medecins Sans Frontieres (MSF) treated 31,000 people with TB in 36
countries, 1,780 of whom had drug-resistant forms of the disease. MSF
responds to the release of the WHO guidelines below:
'The new WHO guidelines on bedaquiline use are welcomed, and are very
timely given the drug's recent approval by the USFDA and the urgent need to
scale-up treatment of drug-resistant TB.
'Regulated, controlled use of bedaquiline is essential in ensuring we don't
burn one of the very few drugs available that could effectively treat
drug-resistant TB.
'As one of the biggest NGO providers of DR-TB treatment, MSF sees people
with increasingly drug-resistant forms of the disease, and without the
development of new drugs that could, in combination with other drugs,
result in shorter, more effective and less toxic regimens, DR-TB will
continue to grow as a global emergency.
'Drug companies and researchers have a big role to play in developing better
new treatment regimens that can be scaled-up and avert a crisis. But that
can only happen if companies collaborate and researchers accelerate studies
of new drug combinations.
'Securing affordability of these medicines will also be critical.'
Dr Jennifer Cohn, Medical Coordinator, Medecins Sans Frontieres Access
Campaign
Joanna Keenan
Press Officer
Medecins Sans Frontieres - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org