Impavido (miltefosine) has been approved to treat the cutaneous form of leishmaniasis, a severe parasitic skin disease estimated to affect millions of people worldwide. This is the first-ever approval of Impavido for this form of leishmaniasis.
The approval also applies for the visceral form (black fever) of leishmaniasis for which Impavido had already received approval by the Indian and German regulatory authorities. Impavido thus becomes the first orally-administered, breakthrough therapy for both visceral and cutaneous leishmaniasis.
Impavido is an alkylphospholipid that has been marketed in India since 2003 through cooperation with the Zydus Cadila Group and is available in Germany via AEterna Zentaris’ partner Paesel + Lorei.
In order to optimize Latin American distribution of Impavido following the approval, AEterna Zentaris has granted distribution rights for Colombia to Tecnofarma, a leading Latin American pharmaceutical company. Tecnofarma thus holds rights to the drug for the entire Latin American territory excluding only Brazil, where Roche has been granted marketing rights.
“Everything is in place for a first delivery of Impavido to Colombia very shortly”, said Professor Jurgen Engel, executive vice president of global R&D and chief operation officer at AEterna Zentaris. “It is our goal to place Impavido as a worldwide standard therapy for both cutaneous and visceral leishmaniasis.”