trending Market Intelligence /marketintelligence/en/news-insights/trending/0ryTgHbF_H9x7fQNtvjEyw2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us
In This List

Menlo Therapeutics itch drug gets US FDA breakthrough therapy status

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help


Menlo Therapeutics itch drug gets US FDA breakthrough therapy status

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.