Geneva, Switzerland - NECT (Nifurtimox-Eflornithine Combination Therapy), a new treatment option against sleeping sickness, a fatal disease which threatens 60 million people across sub-Saharan Africa, has been added to the Essential Medicines List (EML) of the World Health Organization (WHO), based on the application submitted by the non-profit Drugs for Neglected Diseases initiative (DNDi) and supported by Epicentre and Médecins Sans Frontières (MSF).
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 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 for eflornithine and Bayer for 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 programmes of the Republic of the Congo and the 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. 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,” remarked Emmanuel Baron, Director of Epicentre.
“NECT is critical in our efforts to address the needs of neglected patients suffering from a fatal disease,” added Christophe Fournier, MSF's International Council president. “This improved treatment needs to be rolled out urgently to replace the current most commonly used therapy which 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,” commented Bernard Pécoul, Executive Director of DNDi. “No new drugs for stage 2 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.”