Incyte Corporation has announced an extension in the regulatory review process by the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura®). This topical Janus kinase (JAK) inhibitor is intended for the treatment of children aged 2-11 with mild to moderate atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has now been extended by three months to September 19, 2025. This extension allows the FDA additional time to review newly submitted chemistry, manufacturing, and controls data related to the 0.75% strength cream. The sNDA is supported by data from the Phase 3 TRuE-AD3 study, which demonstrated significant efficacy and a consistent safety profile for ruxolitinib cream in the pediatric population.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.