approves Paladin drug to treat tropical disease
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[March 20, 2014]
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
Leishmaniasis occurs primarily in people who live in the tropics and
subtropics. Most U.S. patients acquire the disease while traveling
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
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.
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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)
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