The FDA has approved Impavido (miltefosine; Paladin Therapeutics) for the treatment of three main types of leishmaniasis: visceral leishmaniasis, cutaneous leishmaniasis, and mucosal leishmaniasis in patients ≥12 years of age. This marks the first approved drug for cutaneous or mucosal leishmaniasis.

The approval is based on data from four safety and efficacy clinical trials. A total of 547 patients received Impavido and 183 patients received either a comparator or a placebo. Study results showed that Impavido is safe and effective in treating visceral, cutaneous, and mucosal leishmaniasis.

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Miltefosine is a close analog of lecithin and it has long been assumed that the mechanism of action of miltefosine involves lipid biochemistry. It is thought to relate to the involvement of LdMT, a subunit aminophospholipid translocase, since inactivation of LdMT causes miltefosine resistance both in promastigote and amastigote forms that persists in vivo.

Impavido was granted Fast Track designation, Priority Review, and Orphan Product designation.

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