The oral Impavido has been approved for the three main types of leishmaniasis, including visceral leishmaniasis, cutaneous leishmaniasis and mucosal leishmaniasis. The drug is intended for patients 12 years of age and older.
Visceral leishmaniasis affects internal organs, cutaneous leishmaniasis affects the skin and mucosal leishmaniasis affects the nose and throat.
Paladin Therapeutics claims that Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.
Impavido has received fast track designation, priority review, and orphan product designation from the FDA.
With the new approval, Paladin Therapeutics is awarded a Tropical Disease Priority Review Voucher under a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases.
Safety and efficacy of Impavido has been assessed in four clinical trials, in which a total of 547 patients received Impavido and 183 patients received either a comparator drug or a placebo.
Results from these trials showed that Impavido is safe and effective in treating visceral, cutaneous and mucosal leishmaniasis. Most common side effects identified in clinical trials were nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness and elevated levels of liver enzymes (transaminases) and creatinine.