FDA Approves Paladin's Impavido® For Leishmaniasis

The U.S. Food and Drug Administration (FDA) announced that it has granted approval for Paladin Therapeutics’ Impavido (miltefosine) for the treatment of Leishmaniasis.

A parasite called Leishmania causes the disease Leishmaniasis in humans. Leishmania is commonly transmitted to people through sand fly bites. The disease is primarily observed in people living in tropical and subtropical areas. Most U.S. patients acquire the disease while traveling or staying abroad.

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

Impavido is an oral drug indicated for the treatment of three main types of leishmaniasis. These are visceral leishmaniasis which affects internal organs, cutaneous leishmaniasis which affects the skin, and mucosal leishmaniasis which affects the nose and throat. The drug is intended for patients 12 years old and above. Impavido is the first approved drug to treat cutaneous or mucosal leishmaniasis, the FDA said.

Paladin Therapeutics has previously received fast track designation, priority review, and orphan product designation for Impavido. The high ranking designations were granted because Impavido showed the potential to fill an unmet medical need and offer improvement in treatment safety and efficacy in a serious disease as well as targeting a rare disease. “With this approval, Impavido’s manufacturer, Paladin Therapeutics, is awarded a Tropical Disease Priority Review Voucher under a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases,” said the FDA.

The approval was based on four clinical trials that assessed Impavido’s safety and efficacy. These trials involved 547 patients who received Impavido and 183 who took placebo or a comparator drug. The FDA said trial results showed that the drug is effective and safe to use against visceral, cutaneous and mucosal leishmaniasis.