Researchers have announced that IMPAVIDO® (miltefosine) is the first FDA-approved oral treatment for leishmaniasis, a rare parasitic disease that can lead to severe skin lesions or even life-threatening infections. This medication is specifically indicated for visceral, cutaneous, and mucosal forms of leishmaniasis caused by certain Leishmania species. The U.S. commercialization rights for IMPAVIDO® will be held by Eton Pharmaceuticals starting September 26, 2026.

This new treatment is crucial for individuals at risk of leishmaniasis, which is transmitted through the bites of infected sand flies. The disease can manifest in various forms, with visceral leishmaniasis being the most severe, affecting internal organs and posing significant health risks. For adults and adolescents over 12 years old who weigh more than 66 pounds, having access to an effective oral therapy like IMPAVIDO® could mean a safer and more convenient option for managing this serious condition.

The evidence supporting IMPAVIDO® comes from clinical trials evaluating its effectiveness against specific Leishmania species, although there is some geographic variation in response. While it has been available in the U.S. since 2016, the new commercialization agreement aims to enhance patient access and support for this critical medication. However, it’s important to note that the drug may carry serious risks for pregnant women, including potential birth defects, and should not be used without consultation with a healthcare provider.

If you are concerned about leishmaniasis or think you may be at risk, it’s essential to talk to your healthcare provider about your options and whether IMPAVIDO® could be suitable for you.

Source: globenewswire.com