March 19 (Reuters) - U.S. regulators on Wednesday approved a drug, Impavido, to treat the tropical disease leishmaniasis, which is caused by a parasite transmitted to humans through fly bites.
The drug, also known as miltefosine, is already approved for sale in Europe, the Indian subcontinent and Central and South America.
Leishmaniasis occurs primarily in people who live in the tropics and subtropics. Most U.S. patients acquire the disease while traveling overseas.
Impavido, made by Canada's Paladin Labs Inc, is an oral medicine approved to treat the three main types of leishmaniasis: visceral, which affects internal organs; cutaneous, which affects the skin; and mucosal, which affects the nose and throat.
This is the first drug approved by the FDA to treat cutaneous or mucosal leishmaniasis.
Impavido is intended for patients 12 years of age and older, the agency said in a statement.
The FDA said it granted Impavido fast track designation, priority review and orphan product designation, meaning the drug demonstrated the potential to fill an unmet medical need in a serious disease, the potential to be a significant improvement in the treatment of a serious disease and is intended to treat a rare disease.
The labeling for Impavido includes a boxed warning that the drug can cause fetal harm and should not be given to pregnant women.
Side effects seen in clinical trials of the drug included nausea, diarrhea, headache, dizziness, abdominal pain, itching, drowsiness and elevated levels of liver enzymes. (Reporting by Deena Beasley; Editing by Jan Paschal)