An Indian and an American firms have jointly developed a new lifelong cure for kala-azar, or black fever as visceral leishmaniasis (VL), the second most deadly// parasitic disease in the world following malaria, is known in India.
The drug was prepared by OneWorld Health, a San Francisco charity focusing on treatments for neglected diseases, in collaboration with the Hyderabad-based drug manufacturer Gland Pharma Limited, the American company announced.
The drug is expected to be a key tool for India's National Vector Borne Disease Control Programme (NVBDCP), which aims to rid the country of VL by 2010, and disease control programmes in other VL-endemic countries.
The Drug-Controller General of India (DCGI) has approved Paromomycin Intramuscular (IM) Injection to treat the disease that kills an estimated 500,000 people a year, 90 percent of them in India, Nepal, Bangladesh, Brazil and Sudan.
The application to the DCGI was based on data from a large Phase III multi-centre, randomised and controlled clinical trial of 667 adult and paediatric patients conducted in Bihar State, India, which showed that nearly all patients (94.6 percent) treated with Paromomycin were cured of VL.
A 21-day course of the drug provides a safe, affordable, and effective cure for kala-azar. A full course of treatment stimulates a specific, cell-mediated immune response, resulting in life-long protection from future infection.
The approval of Paromomycin IM Injection is a major milestone in global health, providing a lifelong cure for a deadly parasitic disease, the American firm said.
"With this approval, the Institute for OneWorld Health, with the vital support of our partners, has proven that it is possible to develop new medicines using an entrepreneurial, non-profit model," said OneWorld Health Founder and CEO Victoria G. Hale.
"We are pleased that the first drug in our portfolio will be an impPage: 1 2 3 Related medicine news :1
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