FDA gives approval to Impavido

SILVER SPRING, Md. — The Food and Drug Administration announced the approval of Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites. It's the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.

Impavido is an oral medication 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. It's intended for patients ages 12 years or older.

The disease is prevalent in people who live in the tropics or subtropics; most U.S. patients acquire the disease overseas, the agency said.

“Today’s approval demonstrates the FDA’s commitment to making available therapeutic options to treat tropical diseases,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The labeling for Impavido includes a boxed warning alerting patients and healthcare professionals that the drug can cause fetal harm and shouldn't be given to pregnant women. Healthcare professionals should advise women to use effective contraception during and for five months after Impavido therapy, the agency noted. Common side effects identified in clinical trials were nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness and elevated liver enzymes (transaminases) and creatinine.

Impavido is manufactured by Paladin Therapeutics, which is based in Montreal, Canada.

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