FDA Panel Backs Paladin’s Impavido for Parasitic Diseases

FDA advisors Friday enthusiastically endorsed Paladin’s leishmaniasis drug, Impavido, saying it would provide U.S. patients with the first oral treatment proven to combat three complex and debilitating parasitic diseases. The FDA’s Infective Drugs Advisory Committee voted 15 to 1 that the drugmaker had proven its miltefosine capsules safe and effective for the treatment of visceral leishmaniasis, an often fatal form of a “flesh-eating” infection caused by the bite of female phlebotomine sand flies.
Drug Industry Daily