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FDA panel backs Impavido for leishmaniasis

October 19, 2013 12:29 AM UTC

FDA's Anti-Infective Drugs Advisory Committee was unfazed by FDA reviewers' concerns over trial inconsistencies and resistance to Impavido miltefosine from Paladin Labs Inc. (TSX:PLB). The panel voted 15-1, 14-2 and 13-3 that the company had adequately demonstrated the safety and efficacy of Impavido to treat visceral, cutaneous and mucosal leishmaniasis, respectively. The company is seeking approval for Impavido for all three forms of the disease. The compound has a Dec. 19 PDUFA date. Paladin gained the alkylphosphocholine analog that inhibits CTP phosphocholine cytidylyl transferase from Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS) in 2008. The product is approved for leishmaniasis in Europe, India and Central and South America.

Panelists generally agreed that oral Impavido could offer a useful alternative to IV standard-of-care amphotericin B. Several panelists wanted the label to specify particular species of leishmaniasis and geographical regions, depending on the form of the disease being treated and where the Phase III trials were run. Paladin is asking for a label that specifies different leishmaniasis species in each of the three forms of the disease. ...