MONTREAL — The Food and Drug Administration has approved Impavido, for the tropical disease leishmaniasis, which has plagued U.S. troops deployed to areas such as Iraq.
Leishmaniasis is caused by Leishmania, a parasite which is transmitted to humans through sand fly bites. The disease occurs primarily in people who live in the tropics and subtropics, and most U.S. patients, including military servicemembers, acquire leishmaniasis overseas.
Recent studies have reported that many veterans of Operation Iraqi Freedom were potentially exposed to leishmaniasis, noting that clinicians in both the military and civilian sectors have encounted more cases of leishmiasis in the last decade than any time since World War II.
Impavido is an oral medicine approved to treat the three main types of leishmaniasis: visceral leishmaniasis which affects internal organs; cutaneous leishmaniasis which affects the skin; and mucosal leishmaniasis which affects the nose and throat. Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.
“Today’s approval demonstrates the FDA’s commitment to making available therapeutic options to treat tropical diseases,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The FDA granted Impavido, which is intended for patients 12 years of age and older, fast track designation, priority review and orphan product designation. With this approval, Impavido’s manufacturer, Paladin Therapeutics of Montreal, Canada, is awarded a Tropical Disease Priority Review Voucher under a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
Impavido’s safety and efficacy were evaluated in four clinical trials involving more than 700 study subjects. While 547 patients received Impavido, 183 patients received either a comparator drug or a placebo. Impavido’s label includes a boxed warning to alert patients and healthcare professionals that the drug can cause fetal harm and therefore should not be given to pregnant women. Healthcare professionals also are urged to advise women to use effective contraception during and for five months after Impavido therapy.
The most common side effects identified in clinical trials were nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness and elevated levels of liver transaminases and creatinine.