The global atopic dermatitis market is poised for exceptional growth at approximately 24.1% CAGR during the projection period (2020-2027) (Globe Newswire, 2020). Millions of people continue to be affected by this debilitating skin ailment which in turn escalates the development of new pharmaceutical drugs. Fact: MR projects that the revenue pool of atopic dermatitis market will exceed US$ 19 billion by 2027 (Globe Newswire, 2020).
Atopic dermatitis is a disease of unknown origin that usually starts in early infancy and is typified by pruritis (itch), eczematous lesions, xerosis (dry skin) and lichenification of the skin (thickening of the skin and increase in skin marking). It is the most common skin disease in children, affecting approximately 15% to 20% of children and 1% to 3% of adults (Nutten S, 2015; Eichenfield LF et al, 2014). Population-based studies in the United States suggest that prevalence is about 10.7% for children and 7.2% for adults (Shaw TE et al, 2011; Silverberg JI et al, 2015). Onset of disease commonly presents by 5 years of age, with the highest incidence occurring between the ages of 3 and 6 months, but it can occur at any age (Eichenfield LF et al, 2014, Hanifin JM et al, 2007). Early diagnosis and treatment are essential to avoid complications of AD and improve quality of life (Eichenfield LF et al, 2014). Approximately 60% of patients develop disease in the first year of life and 90% within the first 5 years of life (Eichenfield LF et al, 2014). Twenty percent of children who develop AD before 2 years of age will have persisting symptoms of disease; 17% will have intermittent symptoms by 7 years of age. Only 16.8% of adults with AD experience onset after adolescence (Illi S, 2004; Williams HC et al, 1998; Ozkaya E, 2005). AD commonly resolves by the time a child reaches adulthood; however, approximately 10% to 30% of patients will continue to have symptoms of disease (Ellis CN et al, 2012).
Current treatments for atopic dermatitis (AD) include first line topical emolients, then second line topical or oral corticosteroids and third line topical immunosupressants (calcineurin inhibitors). Antihistamines also appear to be useful agents for AD as they help with the itch.
PDE4 inhibitors, JAK inhibitors and biologics drugs account for a leading share in more severe atopic dermatitis market. All of these medications carry significant safety liabilities, which limit their use to the smaller moderate-severe AD group.
The two topical immunosupressants pimecrolimus (Novartis’ Elidel) and tacrolimus (Astellas’ Protopic) are the leading branded products for AD. Protopic was approved in 2000 and Elidel was approved in 2001. In 2005, a “black box” warning for potential cancer risk was added to the labelling of Novartis’ Elidel and Astellas/Fujisawa’s Protopic, causing a decline in sales of both drugs. Therefore, there is an unmet medical need for a safe efficacious medicine that treats mild to moderate AD, particularly in infants and young children, with the opportunity to expand into severe AD. In addition, new therapies will need to have a significantly improved safety profile compared to current standards of care and which allows them to be deployed for long term treatment in mild to moderate disease and be used in the treatments of infants and young children.
JEL0305 as a topical formulation (cream/ointment) is expected to belcome the first line treatment for AD because of it safety and efficacy.
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