The novel oral helicase-primase inhibitor demonstrated significantly higher rates of complete lesion healing compared with investigator’s choice treatment in the phase 3 PRIOH-1 trial.
No skin lesion flares were observed through 16 weeks after switching from dupilumab to upadacitinib; itch flares occurred in 3.6% to 4.8% of patients with baseline WP-NRS scores of 6 or lower.
The supplemental New Drug Application seeks to expand the use of Ameluz with red light photodynamic therapy beyond the face and scalp to actinic keratoses on the extremities, neck, and trunk.