Geneva, 13 June 2013 – The World Health Organization has today 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 tuberculosis (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 TB – 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, Médecins Sans Frontières (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 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, Médecins Sans Frontières Access Campaign