Eisai First London Declaration Signatory Pre-qualified by WHO to Make NTD Drugs

27-Aug-2013 - Last updated on 28-Aug-2013 at 13:30 GMT

Eisai Pre-qualified by WHO to Make NTD Drugs

Eisai has become the first London Declaration signatory to be pre-qualified to make treatments for neglected tropical diseases by the WHO.

The Japanese drugmaker will produce 2.2bn diethylcarbamazine citrate (DEC) 100mg tablets at its facility in Vizag, India, which will be used to treat lymphatic filariasis as part of a World Health Organisation's (WHO) GPELF programme.

The drug – which has been variously sold as Hetrazan, Carbilazine, Caricide, Cypip, Ethodryl, Notezine, Spatonin, Filaribits and Banocide Forte – has been in short supply for several years, which has severely hampered efforts to eliminate the disease.

In 2010 Eisai was one of 13 pharmaceutical firms to sign the London Declaration, which is an intuitive set up by the public-private partnership Uniting To Combat NTDS that is dedicated to foster the production of treatments.

Formulation Development

To gain WHO prequalification Eisai has already done a lot of work. Shortly after signing the declaration the firm developed a new formulation of DEC and did all the bioequivalence assessments before submitting a request to the WHO in October 2012.

Eisai expects to start producing DEC in Vizag and begin supplying WHO programmes in countries where lymphatic filariasis is endemic in the next few months and predicts that as many as 250 million patients around the world could benefit from treatment.

WHO director general Margaret Chen said: “Eisai's commitment to provide DEC greatly improves prospects for interrupting the transmission of lymphatic filariasis.

"This contribution will eventually close the gap in drug availability, particularly for poor countries where most cases of this disease occur and the burden on health and society is greatest."

Eradication

WHO has been working to eradicate lymphatic filariasis since 2000 when it launched its Global Programme to Eliminate Lymphatic Filariasis (GPELF).

The aim is to eliminate the disease by 2020 through annual mass treatment with a combination of DEC and albendazole. Under the programme – which is also supported by products from GlaxoSmithKline (GSK) and Merck & Co – 2.45bn treatments have been provided in endemic areas.

As a result of these efforts China and the Republic of Korea were declared to have eliminated lymphatic filariasis as a public health problem in 2007 and 2008, respectively.