Eisai Co., Ltd. has received prequalification from the World Health Organization (WHO) for diethylcarbamazine citrate (DEC) 100 mg tablets manufactured at its Vizag plant in India for the treatment of lymphatic filariasis, a neglected tropical disease (NTD). The approval is the first case worldwide in which a pharmaceutical company has received prequalification from WHO for a medicine used to treat an NTD. In 2013, Eisai will begin providing DEC tablets produced for use in mass drug administration programs in each endemic country.
Eisai is a signatory to the London Declaration, which is the largest global public-private partnership to date and aims to eliminate ten NTDs by 2020. The lymphatic filariasis medicine DEC is in short supply worldwide, which poses a major obstacle in eliminating the disease. As part of Eisai’s commitment under the declaration, the company has agreed to produce 2.2 billion high-quality DEC tablets at the Vizag plant and, from 2013, to work with WHO to supply the tablets at price zero to endemic countries over a seven-year period.
Based on this initiative, Eisai developed the formulation and conducted bioequivalence studies before submitting its application to WHO for prequalification in October 2012. After a relatively smooth evaluation process, Eisai was able to receive prequalification for the DEC tablets less than 10 months from submission of the application. The prequalification is a crucial milestone that will see Eisai deliver “Eisai- original,” high-quality DEC tablets to 250 million people living in at-risk communities in countries where lymphatic filariasis is endemic, thereby contributing to successful elimination of
the disease.
In this era of great globalization, Eisai considers its contributions to the economic development and expansion of the middle-income class through the enhancement of health and welfare in developing and emerging countries as a form of long-term investment for future market growth. Eisai remains actively committed to addressing issues in global health including NTDs, in order to better contribute to increasing the benefits provided to patients and their families worldwide.