WHO Adds Combination Therapy to Essential Medicines List
Geneva/New York, May 15, 2009 – A new treatment option for sleeping sickness, a fatal disease that threatens 60 million people across sub-Saharan Africa, has been added to the Essential Medicines List (EML) of the World Health Organization (WHO). The inclusion ofNECT (Nifurtimox-Eflornithine Combination Therapy) is based on an application submitted by the non-profit Drugs for Neglected Diseases initiative (DNDi), supported by the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF), and Epicentre, MSF’s epidemiological research center.
According to the WHO, NECT can now be used in patients and will provide an opportunity to improve the management of sleeping sickness cases. WHO has already made preparations for the arrival of this improved therapeutic opportunity and will work to ensure that patients have access to NECT by providing appropriate training and by supplying the drugs and necessary equipment to disease-endemic countries.
NECT, a co-administration schedule of oral nifurtimox and intravenous eflornithine, is made available through donations to WHO by Sanofi-Aventis (eflornithine) and Bayer (nifurtimox). A pivotal, five-year long Phase III study comparing NECT with eflornithine used alone was recently completed by a partnership including Epicentre, MSF, DNDi, the Swiss Tropical Institute, and the national sleeping sickness control programs of the Republic of the Congo and Democratic Republic of the Congo.
“This study was built on previous Epicentre and MSF studies that identified this particular drug combination as a promising therapy,” said Emmanuel Baron, director of Epicentre. “It has provided some of the strongest evidence in sleeping sickness research to date, and has demonstrated NECT to be a better treatment option for advanced-stage sleeping sickness, as compared with the two current treatments which are either toxic or too complicated to use.”
“NECT is critical in our efforts to address the needs of neglected patients suffering from a fatal disease,” said Christophe Fournier, president of MSF's international council. “This improved treatment needs to be rolled out urgently to replace the current, most commonly used therapy that kills one in every 20 patients.”
“We at DNDi welcome this decision and the rallying by the sleeping sickness community in support of this application as it underscores the practical improvement and impact NECT can make in the field today,” said Bernard Pécoul, executive director of DNDi. “No new drugs for stage two sleeping sickness are expected in the next five years, so there is an urgent need to develop new treatments based on currently available drugs, especially through combinations. However, even with the importance of this development, we have made but one step on the path to ultimately meeting patient needs."