FDA approves Impavido for treatment of Leishmaniasis - Knight Therapeutics
The FDA on 19 March 2014 granted approval to Knight Therapeutics to market Impavido (miltefosine) as a treatment for cutaneous, mucosal and visceral Leishmaniasis, a parasitic disease transmitted by the phlebotomine sand flies and is found in parts of the tropics, subtropics and southern Europe.
These designations were granted because the drug demonstrated the potential to fill an unmet medical need in a serious disease or condition, the potential to be a significant improvement in safety or effectiveness in the treatment of a serious disease or condition, and is intended to treat a rare disease, respectively. 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.
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