BioCentury
ARTICLE | Clinical News

Impavido miltefosine regulatory update

March 24, 2014 7:00 AM UTC

FDA approved an NDA for Impavido miltefosine from Knight Therapeutics 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. ...