FDA Expands Topical Treatment Options for Adolescents with Plaque Psoriasis

Kristen Coppock, MA, Editor
Published Online: Wednesday, July 31st, 2019
Officials with the FDA have expanded the indication for LEO Pharma’s calcipotriene and betamethasone dipropionate (Enstilar) foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 years and older.1 The product was previously indicated only for patients age 18 years and older.2 

In approving the expanded indication, the FDA has extended the period of United States market exclusivity by an additional 6 months to Dec. 10, 2031, according to the company. The action is supported by the Enstilar Pediatric Study (NCT02387853) in adolescents age 12 to 17 years with psoriasis of the body and scalp, and data from trials in adults.1

According to LEO, the new indication provides adolescent patients with plaque psoriasis a once-daily topical treatment option for that they did not previously have available to them. Calcipotriene and betamethasone dipropionate foam is intended for application to affected areas once daily for up to 4 weeks, and patients should not apply more than 60 grams every 4 days. Treatment should be discontinued when control is achieved.1

Adverse reactions reported in <1% of subjects treated with calcipotriene and betamethasone dipropionate foam in clinical trials included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis, according to LEO.2

In announcing the expanded indication for the foam product, LEO also announced the FDA’s approval of calcipotriene and betamethasone dipropionate topical suspension (Taclonex) for the topical treatment of scalp and body psoriasis in patients age 12 years and older.1

The safety and effectiveness of each of these 2 products has not been established  in pediatric patients under age 12 years.1

  1. LEO Pharma Inc. Announces U.S. Food and Drug Administration (FDA) Expanded Regulatory Approvals for Enstilar® Foam and Taclonex® Topical Suspension in Treatment of Plaque Psoriasis [news releasel]. Madison, NJ; July 31, 2019: LEO Pharma. [email]. Accessed July 31, 2019. 
  2. Enstilar® [prescribing information]. Madison, NJ: LEO Pharma Inc.; November 2016. http://enstilar.com/hcp/. Accessed July 31, 2019.

Current Issue

The Educated Patient

Katarzyna Lalicata, MSN, FNP-C, FNP-BC
The symptoms associated with colds, most commonly congestion, coughing, sneezing, and sore throats, are the body's response when a virus exerts its effects on the immune system. Cold symptoms peak at about 1 to 2 days and last 7 to 10 days but can last up to 3 weeks.
Kristen L. Marjama, DNP, APRN-BC, FNP
Exposure to damp and moly environments may also result in a variety of other health issues.
Bethany Rettberg, NPC
An accurate medical history and a physical exam are critical to rule out more serious conditions.
Bethany Rettberg, NPC
Practitioners should get a detailed medical history and conduct a thorough physical to treat sinus infections.
$vacMongoViewPlus$ $vAR$
Contemporary Clinic
MJH Associates
American Journal of Managed Care
MD Magazine
Pharmacy Times
Specialty Pharmacy Times
Targeted Oncology
About Us
Contact Us
Terms & Conditions
Pharmacy Healthcare & Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-257-0701

Copyright Contemporary Clinic 2019
Pharmacy Healthcare & Communications, LLC. All Rights Reserved.