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FDA grants orphan drug designation to miltefosine for Acanthamoeba keratitis

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The FDA has designated miltefosine as an orphan drug for the treatment of Acanthamoeba keratitis, according to a press release from Profounda.

Impavido (miltefosine) was licensed by Profounda from Knight Therapeutics in 2015.

Acanthamoeba keratitis is caused by Acanthamoeba amoebas found in nature and in bodies of water.

“We are pleased with the FDA’s decision to grant orphan drug designation to miltefosine for the treatment of Acanthamoeba keratitis,” Profunda CEO Todd MacLaughlan said in the release. “By creating miltefosine-induced alterations to the membrane architecture of the amoeba, miltefosine allows patients a therapeutic option that has potential advantages over conventional therapy approaches.”