Pfizer Eucrisa Ointment Has Been Approved By The US FDA For Use In Infants And Children Aged ≥3 Months!

- May 07, 2020-

Pfizer recently announced that the US Food and Drug Administration (FDA) has approved Eucrisa (crisaborole, 2% ointment) supplementary new drug application (sNDA) to treat mild to moderate atopic dermatitis (AD, and The name "eczema [eczema]") The minimum age limit for pediatric patients has been extended from 24 months to 3 months.


Eucrisa was previously approved for the treatment of children and adults with mild to moderate AD aged ≥2 years. This approval makes Eucrisa the first and only topical steroid-free prescription drug for pediatric patients with mild to moderate AD aged as low as 3 months.


In China, Eucrisa's marketing application has been accepted by the National Drug Administration (NMPA) Drug Evaluation Center (CDE) on February 10 this year, and the acceptance number is JXHS2000008. Prior to this, the drug was also included in the list of "Second Batch of Clinically Needed New Overseas Drugs". The indications are: mild to moderate specific dermatitis of 2 years old and above.


Atopic dermatitis (AD) is a chronic skin disease characterized by skin inflammation and skin barrier defects. The lesions of AD are characterized by erythema, induration / pimples, and exudation / scabs. In addition to causing physical discomfort, AD can also have a major impact on the emotional and social aspects of personal life. In the United States, AD affects nearly 18 million people and about 11% of children. Early-onset AD is the most common form of disease, starting in the first two years of life. A total of 45% of AD cases start in the first 6 months of life, and 60% start in the first year of life.


This expanded indication approval is supported by research data from CrisADe CARE 1. This is a phase IV, multi-center, open-label, one-arm study. A total of 137 patients with mild to moderate AD infants aged 3 months to 24 months were enrolled. % The safety and efficacy of Eucrisa ointment as an exploratory endpoint.

Eucrisa-crisaborole

The results of the study show that in infants with mild to moderate AD, the use of 2% Eucrisa ointment twice daily has good tolerability, efficacy, and no new safety signals.


Eucrisa (crisaborole, 2% ointment) was developed by American biopharmaceutical company Anacor, and Pfizer bought it for $ 5.2 billion in June 2016. In December 2016, Eucrisa was approved by the US FDA as a topical topical drug for the treatment of mild to moderate atopic dermatitis (AD) in children and adults aged 2 years and older. This approval makes Crisaborole the first new molecular entity approved by the US FDA for the treatment of atopic dermatitis (AD) in the past 15 years.


Eucrisa is positioned as a steroid-free topical therapy for mild to moderate specific dermatitis and is used to replace steroid therapy. The active pharmaceutical ingredient of the drug is crisaborole, which is a non-steroidal PDE4 inhibitor. PDE4 mediates the conversion of cyclic adenosine phosphate (cAMP) to adenosine monophosphate (AMP), thereby reducing intracellular cAMP levels. In normal physiology, high levels of cAMP in T cells and other immune cells can suppress the production of inflammatory mediators. White blood cells and monocytes in AD patients show low levels of cAMP and abnormally high PDE activity, and increased PDE activity is related to inflammatory reactivity. Inhibition of PDE, including PDE4, can reduce the release of pro-inflammatory cytokines. Compared with non-AD individuals, PDE in white blood cells of AD individuals showed a high sensitivity to PDE inhibitors.


Data from two placebo-controlled phase III clinical studies show that in patients with mild to moderate atopic dermatitis from 2 to 79 years of age, Eucrisa treatment can significantly improve the patient's condition and complete rash compared with placebo for 28 days. Subsided or almost completely subsided. Long-term safety studies have shown that Eucrisa is well tolerated and safe for 12 months of intermittent use.