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
– FDA approves Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis in patients 12 years and older; Agency grants pediatric exclusivity extending U.S. market exclusivity –
– FDA approves Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension for the treatment of plaque psoriasis of the scalp and body in patients 12 years and older–
MADISON, NJ, USA I August 01, 2019 I LEO Pharma Inc., a wholly owned subsidiary of LEO Pharma A/S, announced today the U.S. Food and Drug Administration (FDA) has expanded the approved indication for Enstilar® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The FDA granted Enstilar Foam pediatric exclusivity, extending the period of U.S. market exclusivity by an additional six months to Dec. 10, 2031.
This expanded indication is supported by the Enstilar Pediatric Study (NCT02387853) in adolescents age 12 to 17 with psoriasis of the body and scalp, as well as data from adequate and well-controlled trials in adults.
“Healthcare 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,” said Joyce Teng, MD, PhD, Professor of Dermatology and Pediatrics at Stanford University, and study investigator. “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.”
Enstilar is the leading prescribed branded topical treatment for plaque psoriasis.1
Additionally, the FDA approved Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.
“Our mission is to help people achieve healthy skin,” said Chris Posner, U.S. President and Chief Executive Officer of LEO Pharma Inc. “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.”
Clinical trial details and study results can be found at clinicaltrials.gov.
The safety and effectiveness of Enstilar Foam and Taclonex Topical Suspension in pediatric patients under 12 years of age have not been established.
About Enstilar® Foam
Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.
INDICATION AND USAGE
Enstilar (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.
Apply Enstilar to affected areas once daily for up to four weeks. Patients should discontinue use when control is achieved. Patients should not use more than 60 grams every four days.
About Taclonex® Topical Suspension
Taclonex Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.
INDICATION AND USAGE
Taclonex Topical Suspension is a prescription medicine that is to be used on the skin to treat plaque psoriasis of the scalp and body in patients 12 years of age and older.
Apply Taclonex Topical Suspension to affected areas on the scalp and body one time a day for up to 8 weeks. You should stop treatment when your plaque psoriasis is under control, unless your doctor gives you other instructions. Patients greater than 18 years should not use more than 100 grams per week. Patients age 12 to 17 years should not use more than 60 grams per week. Use Taclonex Topical Suspension exactly as your doctor tells you to use it.
About Psoriasis
Psoriasis is a chronic, systemic inflammatory skin disease that is estimated to affect about 3.2% of the U.S. population.2 About 80% of patients are affected by mild or moderate plaque psoriasis, the most common clinical form of psoriasis.3 Topical treatments are first-line therapies for the majority of patients.
About LEO Pharma
LEO Pharma Inc. is a wholly owned subsidiary of LEO Pharma A/S. LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 5,500 people, serving 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million – more than $1.5 billion (USD). For more information, visit www.leo-pharma.us and www.leo-pharma.com.
The LEO Pharma logo, LEO Pharma, Enstilar and Taclonex are registered trademarks of LEO Pharma A/S. ©2019 LEO Pharma Inc. All rights reserved. July 2019 MAT-27179
1 IQVIA NPA data on file [May 2018 – June 2019].
2 Rachakonda, T., Schupp, C., and Armstrong, A.W. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014; 70: 512–516
3 Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol; 2008 May;58(5):826-50.
SOURCE: LEO Pharma
Post Views: 83
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
– FDA approves Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis in patients 12 years and older; Agency grants pediatric exclusivity extending U.S. market exclusivity –
– FDA approves Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension for the treatment of plaque psoriasis of the scalp and body in patients 12 years and older–
MADISON, NJ, USA I August 01, 2019 I LEO Pharma Inc., a wholly owned subsidiary of LEO Pharma A/S, announced today the U.S. Food and Drug Administration (FDA) has expanded the approved indication for Enstilar® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The FDA granted Enstilar Foam pediatric exclusivity, extending the period of U.S. market exclusivity by an additional six months to Dec. 10, 2031.
This expanded indication is supported by the Enstilar Pediatric Study (NCT02387853) in adolescents age 12 to 17 with psoriasis of the body and scalp, as well as data from adequate and well-controlled trials in adults.
“Healthcare 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,” said Joyce Teng, MD, PhD, Professor of Dermatology and Pediatrics at Stanford University, and study investigator. “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.”
Enstilar is the leading prescribed branded topical treatment for plaque psoriasis.1
Additionally, the FDA approved Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.
“Our mission is to help people achieve healthy skin,” said Chris Posner, U.S. President and Chief Executive Officer of LEO Pharma Inc. “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.”
Clinical trial details and study results can be found at clinicaltrials.gov.
The safety and effectiveness of Enstilar Foam and Taclonex Topical Suspension in pediatric patients under 12 years of age have not been established.
About Enstilar® Foam
Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.
INDICATION AND USAGE
Enstilar (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older.
Apply Enstilar to affected areas once daily for up to four weeks. Patients should discontinue use when control is achieved. Patients should not use more than 60 grams every four days.
About Taclonex® Topical Suspension
Taclonex Topical Suspension is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.
INDICATION AND USAGE
Taclonex Topical Suspension is a prescription medicine that is to be used on the skin to treat plaque psoriasis of the scalp and body in patients 12 years of age and older.
Apply Taclonex Topical Suspension to affected areas on the scalp and body one time a day for up to 8 weeks. You should stop treatment when your plaque psoriasis is under control, unless your doctor gives you other instructions. Patients greater than 18 years should not use more than 100 grams per week. Patients age 12 to 17 years should not use more than 60 grams per week. Use Taclonex Topical Suspension exactly as your doctor tells you to use it.
About Psoriasis
Psoriasis is a chronic, systemic inflammatory skin disease that is estimated to affect about 3.2% of the U.S. population.2 About 80% of patients are affected by mild or moderate plaque psoriasis, the most common clinical form of psoriasis.3 Topical treatments are first-line therapies for the majority of patients.
About LEO Pharma
LEO Pharma Inc. is a wholly owned subsidiary of LEO Pharma A/S. LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 5,500 people, serving 76 million patients in 130 countries. In 2018, the company generated net sales of DKK 10,410 million – more than $1.5 billion (USD). For more information, visit www.leo-pharma.us and www.leo-pharma.com.
The LEO Pharma logo, LEO Pharma, Enstilar and Taclonex are registered trademarks of LEO Pharma A/S. ©2019 LEO Pharma Inc. All rights reserved. July 2019 MAT-27179
1 IQVIA NPA data on file [May 2018 – June 2019].
2 Rachakonda, T., Schupp, C., and Armstrong, A.W. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014; 70: 512–516
3 Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol; 2008 May;58(5):826-50.
SOURCE: LEO Pharma
Post Views: 83
