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FDA Approval of New Tuberculosis Drug is Only One Step in Addressing Drug-Resistant Strains

Note: World Lung Foundation united with The Union North America. From January 2016, the combined organization is known as “Vital Strategies.”

(New York, USA) – World Lung Foundation today welcomed the U.S. Federal Drug Administration’s approval of Sirturo, a new treatment for multi-drug resistant tuberculosis (TB), but it also cautioned that limited clinical trial data mean there may still be unknown risks. The foundation called for a comprehensive approach to preventing and managing drug resistant strains, with a focus on basic TB control.

Dr. Neil Schluger, Chief Scientific Officer, World Lung Foundation, noted: “Sirturo is the first novel drug introduced to treat TB in over 40 years, and it represents an exciting step forward in this fight. The World Health Organization estimates that there may be 500,000 persons in the world with multidrug resistant TB, and this agent represents new hope for many of those patients. However, the safety warnings associated with this new drug highlight the need for continuing and strengthening efforts to find effective new drugs to treat all patients with TB—those with drug resistant AND drug susceptible strains.

“In addition to adding a new last line of defence, governments must proactively fight new cases of TB and treat them early on. Catching the disease early enables simpler treatment, stops the disease’s spread and saves keeps drug resistant strains at bay. Unfortunately, basic TB control is difficult, grinding work that isn’t as appealing to donors as a new medicine. The painstaking process of basic TB treatment remains severely under-resourced, especially in the world’s poorest countries where the disease is most prevalent.”

World Lung Foundation recommends a six-step approach to combat the increasing threat of TB and its drug-resistant strains:

1. Improved advocacy to gain attention for TB among health ministries, governments and funders around the world.
2. Existing tools of proven value – like simple diagnostics such as sputum smears for suspected TB cases – must be available globally.
3. Novel sophisticated diagnostics – such as molecular techniques capable of diagnosing drug-resistant tuberculosis within hours – should be quickly but carefully integrated into national TB control programs, without impacting other basic aspects of TB control.
4. An uninterrupted drug supply of first and second-line drugs must be assured and must be made a priority of national governments, health ministries, and TB control programs.
5. Programs of directly observed therapy (DOTS) should be supported and strengthened.
6. Accurate surveillance of cases and reporting must be made a priority, so that trends in rates of drug susceptible and resistant disease can be closely tracked and responded to.