March 19 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
The drug, also known as miltefosine, is already approved for
sale in Europe, the Indian subcontinent and Central and South
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
The labeling for Impavido includes a boxed warning that the
drug can cause fetal harm and should not be given to pregnant
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)