February 17, 2016
As a part of the lymphatic filariasis (LF) elimination activities led by the World Health Organization (WHO), a new public-private partnership has been initiated to provide diagnostic kits free of charge, for use in evaluating the success of mass drug administration (MDA) in LF elimination and helping to determine when MDA can stop. Eisai is also taking part in the partnership.
In this partnership, the Bill and Melinda Gates Foundation as well as three pharmaceutical companies who provide medicine for LF elimination (Eisai, GlaxoSmithKline and Merck known as MSD outside the U.S. and Canada) have participated in discussions to improve the Filariasis Test Strip (FTS) diagnostic kit from the development stage. The partners are providing joint funding for the procurement of the test so that it can be supplied to countries that need it throughout the world.
At a follow-up meeting to the London Declaration held in Paris in April 2014, the abovementioned partners announced a plan to support the rollout of a new FTS which is lower-cost and more stable than the currently used diagnostic kit. Since then, WHO has been coordinating supply and preparation with Alere Inc., the company responsible for development and manufacture of the FTS, for distribution to countries that need the diagnostic kits. Supply commenced during 2015, and WHO officially announced the partnership to supply the diagnostic kits in February 2016.
MDA must be conducted in LF endemic areas for a period of five years usually in order to eliminate the disease, however, completing MDA alone does not necessarily mean the disease has been “eliminated”. In order to declare elimination status, a fixed point observation study (Transmission Assessment Survey, “TAS”) to ascertain the state of filariae infection must first be fully conducted for an additional two to four years after MDA. The FTS is used in the fixed point observation study to assess the filariae infection rate of residents in a target area, and determines changes in the infection rate. Although TAS will need to be carried out on a large scale in order to eliminate LF by 2020, the current diagnostic kits require transport at low temperatures. The new FTS provided through the partnership is not only more stable than the current kit from a logistics point of view and easier to operate, the cost of the kit is getting lower. The FTS will enable TAS in places where it is required throughout the world, and will provide data that forms the very important scientific evidence for determining whether to continue or stop MDA. Furthermore, the results of TAS can be used to improve the precision of supply plans of medicines between WHO and donors.
Although the supply of the FTS to local areas will be provided by WHO with the support of the public-private partnership in some situations and provided in other situations through various government organizations (including the U.K. Department for International Development, the Japan International Cooperation Agency and the United States Agency for International Development) who support endemic countries, WHO will coordinate all together the countries that require the FTS and in what quantity. WHO estimates that 750,000 kits will be required in 2016.
Together with supplying DEC tablets, Eisai will continue to contribute to the early elimination of LF using a comprehensive approach that features collaborative research and development for new medicines, the supply of diagnostic kits to confirm elimination, raising awareness of disease through hhc activities and the initiatives of DEC Project Managers.