BioCentury
ARTICLE | Company News

Priority Review for Paladin's leishmaniasis compound

June 20, 2013 12:56 AM UTC

Paladin Labs Inc. (TSX:PLB) said FDA accepted and granted Priority Review to an NDA for Impavido miltefosine to treat leishmaniasis. The PDUFA date is Dec. 19. Paladin said it is eligible for a Priority Review voucher if FDA approves the application. The transferrable voucher entitles the bearer to priority FDA review for another drug. The voucher program was started in 2007 to create incentives to develop drugs for neglected tropical diseases (see BioCentury, Aug. 8, 2011).

Impavido is already marketed for leishmaniasis in Europe, India and Central and South America. Paladin acquired the alkylphosphocholine analog that inhibits CTP phosphocholine cytidylyl transferase from Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS) in 2008. ...