Axovant Sciences Receives US FDA Fast Track Status for Nelotanserin

Axovant Sciences has announced that the US Food and Drug Administration (FDA ) has granted Fast Track designation to its investigational drug nelotanserin for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).

Dementia with Lewy bodies is the second-leading form of progressive dementia and affects over 1 million people in the United States. Currently, there are no approved therapies for the disease in the United States or in Europe.

"We are pleased that the FDA has granted nelotanserin Fast Track designation ," said David Hung, M.D., chief executive officer of Axovant. "Patients in the United States with DLB who experience frequent visual hallucinations have no approved treatment options and we hope to work closely with the FDA as we seek to address the needs of this underserved patient population as quickly and efficiently as possible."

Nelotanserin is a novel 5HT2A inverse agonist being investigated in a Phase 2 double-blind, randomized, placebo-controlled crossover safety study involving more than 20 subjects diagnosed with Lewy body dementia who experience frequent visual hallucinations. In addition, nelotanserin is being investigated in a Phase 2 double-blind, randomized, placebo-controlled study involving up to 60 subjects diagnosed with Lewy body dementia who have REM sleep disorder.

Fast Track designation is a process designed to facilitate the development, and expedite the review, of important new drugs to treat serious conditions which fill unmet medical needs in order to get them to patients earlier. Early and frequent communications between the FDA and the sponsor throughout the drug development and review process help ensure that questions are resolved quickly, often leading to earlier drug approval.