Menlo Therapeutics Inc.'s medicine serlopitant has been granted the U.S. Food and Drug Administration's breakthrough therapy designation to treat a type of skin disease.
The Redwood City, Calif-based pharmaceutical company said serlopitant was granted the status to treat pruritus, or itching associated with prurigo nodularis, a skin disease characterized by itchy swellings on the arms and legs. The company's request for the breakthrough therapy designation was supported by positive results from a mid-stage study.
The FDA's breakthrough therapy status allows for expedited development and review of drugs that show improvement compared to existing therapies for treating a serious or life-threatening disease.
Menlo is enrolling patients in two phase 3 studies of serlopitant for treating pruritus associated with prurigo nodularis and plans to evaluate the drug to treat itching associated with psoriasis in a separate late-stage study. The company's development program for the drug also includes a mid-stage study for chronic pruritus of unknown origin.