FDA Approves Clenbuterol Ointment (2%) For Supplementary New Drug Application For Extended Indications For Children With Mild To Moderate Atopic Dermatitis From 3 Months To 2 Years Old

- Feb 24, 2020-

Pfizer Inc. (NYSE: Pfizer) has announced that the US Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) Cliborol Ointment (2%) and will have mild to moderate atopy The age limit for children with dermatitis AD (eczema) has been extended from 24 months to 3 months. Clenbuterol has been approved for adults and children over 2 years of age2. This supplemental approval makes Clebolol the first and only non-steroidal topical prescription drug for patients with mild to moderate atopic dermatitis AD (eczema) from 3 months to 2 years old.


At the same time, the European Commission has recently approved the use of clibolol ointment (20mg / g) for the treatment of mild to moderate atopic dermatitis (eczema) in patients over 2 years of age and whose skin disease area is less than 40%. This is the first non-hormonal topical drug approved for European patients in the past decade.

"Families of patients often spend hours every day trying to relieve their children's eczema symptoms; both babies and caregivers are affected. This is something I can see in daily practice and it affects the entire family of patients," San Diego Lawrence Eichenfield, MD, Director of Pediatrics and Adolescent Dermatology, Associate Director of Dermatology, and Professor of Dermatology and Pediatrics at the University of California San Diego School of Medicine Younger patients offer hope for potential relief. "


AD is a chronic skin disease characterized by skin inflammation and skin barrier defects. It affects nearly 18 million people and about 11% of children in the United States. Early-onset eczema is the most common and frequently occurring disease in the first two years of life. Of all AD cases, 45% of patients developed the disease within the first 6 months after birth, and 60% of patients developed the disease within the first year after birth.


Professor Ma Lin, director of the Department of Dermatology of Beijing Children ’s Hospital, pointed out: “In China, the incidence of atopic dermatitis from 1 to 7 years old reaches 12.94%. The younger the child, the higher the incidence. , The child is uncomfortable and cannot fall asleep, affecting his normal growth and development, and even the quality of life of the entire family. And it is also a recurrent disease, if it is not effectively controlled for a long time, it may cause a series of diseases such as asthma and allergic rhinitis , Food protein allergies, etc., make the disease more serious, and will also bring a huge economic burden to society. "


Clebolol's expanded indication approval is supported by data from a phase 4 open-label clinical study; the study was designed to evaluate children with mild to moderate AD from 3 months to less than 24 months Safety, and its effectiveness as an exploratory end point. In this study, 2% of cribolol ointment was well tolerated and showed effectiveness in patients with mild to moderate AD, and no new safety signs appeared.


"For atopic dermatitis, existing treatments have many limitations, such as glucocorticoids, long-term use will often have some side effects." Professor Ma Lin said: "Crebolol ointment is a non-hormonal small molecule drug, It just fills the gap in the treatment of atopic dermatitis (eczema) and brings a new treatment option for children with AD. At present, the drug has been marketed in Europe and the United States and other countries, looking forward to entering China as soon as possible, so that Chinese children Use this innovative medicine as soon as possible. "


Richard Blackburn, Pfizer ’s Global President of Inflammation and Immunology, said: “Although atopic dermatitis usually manifests in infancy, the current treatment plan for this population is rarely approved. We are committed to bringing about Changes in meaning; with the extension of the indications, we look forward to helping many children with eczema now. "


Note: This product has not yet been approved in China, and the information mentioned in this news should not be used as a medical recommendation or promotion under any circumstances.

 

About CrisADe CARE 1 research


The sNDA report was submitted based on data from the Phase 4 CrisADe CARE 1 trial. This four-week, multi-center, open-label, single-arm study evaluated the safety of cribolol ointment (2%); it was applied twice a day to 137 pediatric patients aged 3 months to 24 months. Effectiveness will be used as an exploratory endpoint. All patients with mild to moderate AD include 5% treatable body surface area (% BSA), but not scalp. Twenty-one of the 137 subjects were included in the pharmacokinetic (PK) assessment subgroup and were clinically diagnosed with moderate AD and at least 35% treatable% BSA (excluding the scalp).


About atopic dermatitis


Atopic dermatitis (AD) (eczema) is a chronic skin disease characterized by skin inflammation and skin barrier defects. The lesions of AD are characterized by erythema (redness), hardening or the formation of papules, exudate, and crusting.


In addition to causing physical discomfort, AD can also have a major impact on the emotional and social aspects of personal life9,10. AD may also have a negative impact on the patient's family, and the impact of AD on children's health-related quality of life may be greater than diabetes.


About 50% of children with AD worldwide have recurrent symptoms during adolescence and adulthood.


About Cribolo (2%) ointment


Clenbuterol (2%) ointment is a new non-steroidal topical phosphodiesterase (PDE4) inhibitor. It is approved in the United States as EUCRISA® (Cliborol (2%) ointment) for topical treatment of adults with mild to moderate AD in children 3 months and older. Clebolol is approved as EUCRISA® (Clebrolol (2%) ointment) in Canada and STAQUIS ™ (Clebrolol (2%) ointment) in Israel and Australia, and will be used Mild to moderate atopic dermatitis (AD) (eczema) in patients 2 years of age and older.