FDA approves Impavido to treat tropical disease leishmaniasis

The US Food and Drug Administration yesterday approved Canada-headquartered Paladin Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Paladin was acquired by the USA’s Endo Health Solutions (Nasdaq: ENDP) in a $1.6 billion deal completed last month (The Pharma Letter November 6 2013).

Impavido is an oral medicine approved to treat the three main types of leishmaniasis: visceral leishmaniasis (affects internal organs), cutaneous leishmaniasis (affects the skin) and mucosal leishmaniasis (affects the nose and throat). It is intended for patients 12 years of age and older. Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.

“Today’s approval demonstrates the FDA’s commitment to making available therapeutic options to treat tropical diseases,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.