The FDA has expanded the indicated patient population for Enstilar foam for topical treatment of plaque psoriasis to include patients aged 12 years and older, according to a press release from Leo Pharma.
The FDA granted Enstilar foam (calcipotriene 0.005% and betamethasone dipropionate 0.064%) pediatric exclusivity, which extends the period of U.S. market exclusivity by 6 months to Dec. 10, 2031, according to the release.
The Enstilar Pediatric Study supports the expanded indication in adolescents aged 12 to 17 years with psoriasis of the body and scalp.
“Health care professionals now have a once-daily topical treatment option with Enstilar for their adolescent patients age 12 and older who are affected by plaque psoriasis,” study investigator Joyce Teng, MD, PhD, professor of dermatology and pediatrics at Stanford University, said in the release. “Managing adolescents with body and scalp plaque psoriasis can be very challenging for dermatologists. We welcome this U.S. FDA approval for these children with unmet medical needs.”
The company also announced that Taclonex topical suspension (calcipotriene and betamethasone dipropionate) has been approved for patients 12 years and older for the topical treatment of plaque psoriasis of the body and scalp.
“These regulatory milestones expand the potential we have to make a difference in the lives of adolescents 12 years and older who are affected by plaque psoriasis. Plaque psoriasis is a condition that can cause physical and social discomfort, and can significantly affect quality of life,” Chris Posner, U.S. president and CEO of Leo Pharma, said in the release.