Profounda Launches Impavido for Visceral, Mucosal and Cutaneous Leishmaniasis


Profounda, Inc. launched Impavido (miltefosine) in the United States. Impavido is the first oral treatment for visceral, mucosal and cutaneous leishmaniasis approved by the FDA and the first Rx product launched in the US by Profounda.

Although skin sores of cutaneous leishmaniasis (CL) usually heal on their own, even without treatment, it can take months or even years, and the sores can leave ugly scars on some patients. Leishmania disseminates from the skin to the nasooropharyngeal mucosa, resulting in mucosal leishmaniasis (ML) and destruction of nasal and pharyngeal structures. Death may occur due to complicating aspiration pneumonia. Mucosal leishmaniasis might not be noticed until years after the original sores healed. The best way to prevent mucosal leishmaniasis is to ensure adequate treatment of the cutaneous infection. Visceral leishmaniasis (VL) is the result of systemic infection. Clinical manifestations include fever, hepatomegaly, splenomegaly, and bone marrow involvement with pancytopenia. VL is fatal if untreated. There are no other current FDA approved drugs for the treatment of CL or ML other than Impavido.

Clinicians can find out more about how to order Impavido for their patients or how to have the ability to have Impavido on consignment by visiting

"Making such an important treatment option for leishmaniasis available in the United States will help those very few patients who need this important therapy," said Todd MacLaughlan, CEO of Profounda. "With the launch of Impavido, we look forward to working with the infectious disease community to create awareness about the disease and this newly available treatment option."

"Impavido is approved for sale in Germany, India, Israel, and the United States and has been helping patients suffering from leishmaniasis since 2002. We are pleased that Profounda has taken the initiative to make this medically important medicine available to Americans. Impavido will touch the lives of US patients to our immense delight," said Jonathan Goodman, President and CEO of Knight.

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