India licenses the first oral drug for leishmaniasis

Published: 29-Jul-2002


A new oral treatment for leishmaniasis, also known as black fever, has been licensed in India - the country which is worst affected by the disease. Miltefosine (Impavido from Zentaris) is expected to cost less and is much easier to deliver than all current therapies. In clinical trials, it cured 95% of treated patients.

Miltefosine is the first oral drug against leishmaniasis and was taken from laboratory bench through to registration in six years, thanks to a collaboration between the government of India, the drug's manufacturer, German biopharmaceutical company Zentaris, and TDR (Tropical Diseases Research), a programme co-sponsored by the World Bank, the UN Development Programme and the WHO.

Leishmaniasis is a parasitic disease transmitted through the bite of the sandfly. Its visceral form affects some 500,000 people a year and it accounts for some 60,000 fatalities. It is one of the 'neglected diseases' affecting the world's poorest people, which have become a special focus at WHO. The Indian government hopes eliminate visceral leishmaniasis by 2010.

Until now, all treatments for the disease have had substantial drawbacks: some are toxic and can cause permanent, irreversible damage such as diabetes, while other drugs trigger dangerous reactions. Furthermore, up to 60% of cases in India are now resistant to the first line drug.

Ninety percent of all cases occur in five countries: India, which has the greatest burden, Bangladesh, Brazil, Nepal and Sudan.

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