BioCentury
ARTICLE | Company News

FDA approves Impavido

March 20, 2014 12:48 AM UTC

FDA approved Impavido miltefosine from Knight Therapeutics Inc. (TSX-V:GUD) to treat cutaneous, mucosal and visceral leishmaniasis. The agency said Impavido is the first drug approved for cutaneous or mucosal leishmaniasis. Knight said it could not yet comment on a launch timeline or pricing. With Impavido's approval, the company received a voucher under FDA's Tropical Disease Priority Review voucher program. The transferrable voucher entitles the bearer to obtain Priority Review of any subsequent NDA or BLA that otherwise would receive a standard review (see BioCentury, Aug. 8, 2011).

Knight was formed this month by former shareholders of Paladin Labs Inc. to house Impavido after Paladin's acquisition by fellow specialty pharma Endo International plc (NASDAQ:ENDP; TSX:ENL). Impavido, an alkylphosphocholine analog, is approved for leishmaniasis in Europe, India and Central and South America. ...