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Paladin Gets FDA Approval for Impavido

March 21, 2014

The FDA has approved Paladin Therapeutics’ oral drug Impavido to treat leishmaniasis, a tropical disease caused by parasites. It is approved for patients at least 12 years of age and weighing more than 66 pounds, the agency said Thursday.

Impavido (miltefosine) is the first FDA-approved treatment for mucosal and cutaneous leishmaniasis; the agency approved San Diego, Calif.-based NeXstar Pharmaceuticals’ intravenous AmBisome (liposomal amphotericin B) for visceral leishmaniasis in August 2007. NeXstar was acquired by Gilead Sciences in 1999.

Results of clinical studies of 547 patients given Impavido in India, Colombia, Brazil, Bolivia and Guatemala and 183 patients given a comparator drug or a placebo bolstered the drug’s safety and efficacy profiles across all three forms of the disease, the FDA said.

An advisory committee concluded in October that the benefits of the drug outweighed its risks of adverse events and drug interactions. Impavido can be given on an outpatient basis, the advisors stressed, minimizing clinic visits often required with previous standard leishmaniasis treatments. Because the disease manifests in different ways in different regions and is spread by different types of sand flies, however, the labeling contains a warning that infections acquired in different regions may respond differently to the drug.

Impavido received fast track designation, priority review and orphan drug status. The agency also granted the drugmaker a tropical disease priority review voucher under a provision of the Food and Drug Administration Amendments Act of 2007 that incentivizes development of new drugs for prevention and treatment of tropical diseases, the FDA said. — Lena Freund

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