FDA Grants Orphan-Drug Status to 'Black Fever' Treatment

The FDA has granted orphan-drug designation to the Institute for OneWorld Health's paromomycin, an antibiotic intended to treat visceral leishmaniasis (VL).

VL, also known as kala azar ("black fever"), is a fatal disease transmitted by sand flies, which spread leishmania parasites that attack internal organs. OneWorld Health said it would first seek approval for the drug in India, where VL is most prevalent. The firm said it plans to begin the drug-approval process in the U.S. in 2006.

OneWorld Health is a U.S.-based nonprofit pharmaceutical company that focuses on developing affordable medicines for infectious diseases that disproportionately affect people in the developing world.