Shots:
- The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitable
- sNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%, or vehicle BID, and those completing the initial 8-wk efficacy phase could enter a 44-wk long-term safety extension
- 1EP met with significantly more pts achieving Investigator’s IGA-TS at Wk 8 vs receiving a non-medicated cream and 2EPs, including achieving at least 75% improvement in the EASI75. The safety profile remained consistent with previous studies
Ref: Incyte | Image: Incyte | Press Release
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