INDIA APPROVES TREATMENT FOR VISCERAL LEISHMANIASIS

The Institute for OneWorld Health, a nonprofit pharmaceutical company, announced that the Drugs Controller General of India has approved Paromomycin Intramuscular Injection for the treatment of visceral leishmaniasis, the second most deadly parasitic disease after malaria, according to the organization.

The approval of came less than three months after the submission of the drug's application, which was prepared by OneWorld Health in collaboration with Indian drugmaker Gland Pharma. The application was based on data from a large Phase III multicenter, randomized and controlled clinical trial of 667 adult and pediatric patients that showed nearly all visceral leishmaniasis patients (94.6 percent) treated with Paromomycin were cured.

A 21-day course of the drug provides a safe, affordable, and effective cure for the disease, locally known as kala-azar. A full course of treatment stimulates a specific, cell-mediated immune response, resulting in lifelong protection from future infection. The drug is expected be a key tool for India's National Vector-Borne Disease Control Programme, which aims to rid the country of visceral leishmaniasis by 2010. Gland Pharma will make the medicine available for approximately $10 per person.