FDA Approves Paladin Lab's Impavido For Leishmaniasis
By Cyndi Root
The Food and Drug Administration (FDA) announced in a press release that it has approved Paladin Lab’s Impavido. The drug is orally administered to patients with the tropical disease leishmaniasis. Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said, “Today’s approval demonstrates the FDA’s commitment to making available therapeutic options to treat tropical diseases.”
Leishmaniasis
The parasite Leishmania causes leishmaniasis. Humans visiting the subtropics, tropics, and parts of southern Europe are susceptible to the parasite when it is transmitted by phlebotomine sand fly bites. Cutaneous leishmaniasis causes skin sores. Visceral leishmaniasis affects internal organs. Mucosol leishmaniasis affects the throat and nose. The Centers for Disease Control (CDC) classifies leishmaniasis as a Neglected Tropical Disease (NTD). This group of bacterial and parasitic diseases causes about one billion people to experience illness, pain, lack of productivity, and death.
Impavido
Impavido (miltefosine) is an alkyllysophospholipid analogue that acts against the Leishmania species. Miltefosine is thought to interact with lipids, inhibit mitochondrial action, and instigate cell death. The drug travels into the cell via proteins in the parasite’s plasma membrane. Miltefosine treats the different types of leishmaniasis, visceral, cutaneous, and mucosal. The drug is meant for people over the age of 12 years of age.
FDA Approval
The FDA granted Impavido several advantages in the review process because the need for a new drug is serious and it has the potential to be safe and effective. The application was fast tracked, given priority review, and designated as an orphan drug. Additionally, under the FDA Amendments Act of 2007, the federal agency gave the drug’s sponsor a Tropical Disease Priority Review Voucher, intended to support drug developers to prioritize tropical disease medications.
Impavido Clinical Trials
The FDA relied on clinical trials of Impavido when reviewing the application. Four clinical trials enrolled 730 people. Some took Impavido and others took a placebo or a comparable drug. Results showed safety and effectiveness in treating the three kinds of leishmaniasis. Side effects included vomiting, diarrhea, dizziness, itching, and drowsiness. Pregnant women should not take the drug as it may cause fetal harm.
Paladin Therapeutics
Paladin Therapeutics is headquartered in Montreal, Canada. Recently, the company announced in a press release that it had been acquired by Endo International. Endo has headquarters in Ireland and the U.S.