Atopic dermatitis (AD), also known as atopic eczema, is a chronic, pruritic, relapsing inflammatory dermatological condition. The condition usually begins during early infancy and childhood, but can persist into, or start during, adulthood. AD usually fluctuates between periods of relative flares and quiescence; however, some individuals have chronically active disease. The exact cause of the disease is unknown; however, certain factors such as epigenetic, genetic, immunological, and environmental interactions with overlapping skin barrier defects are indicated in its pathogenesis. The disease significantly affects the quality of life of the patient and their family, which further causes serious socioeconomic consequences. An imbalance of the Th22 and Th2 cytokines which causes the disruption of keratinocytes is thought to be an important contributing factor that drives AD pathogenesis. Furthermore, impaired skin barrier function due to mutations in the epidermal barrier protein, filaggrin, could also play a crucial role in the development of AD by increasing the penetration of microbes and allergens.
Key Takeaways
Key Takeaways
- The approved drugs in the atopic dermatitis space focus on a wide variety of targets. These drugs are commonly administered via the topical route, with a few select products being available in oral, intramuscular, intravenous, and subcutaneous formulations.
- The majority of industry-sponsored drugs in active clinical development for atopic dermatitis are in Phase II, with one drug in the NDA/BLA phase.
- Pipeline drugs in development for atopic dermatitis focus on a wide variety of targets. The largest proportion of drugs in development are administered via the topical route, with the remainder being oral, subcutaneous, intravenous, and intranasal formulations.
- High-impact upcoming events for drugs in the atopic dermatitis space comprise topline Phase II, Phase IIb, Phase II/III, and Phase III trial results; expected CHMP opinions; and an expected PDUFA date for a BLA.
- The overall likelihood of approval of a Phase I allergy asset is 12%, and the average probability a drug advances from Phase III is 64.7%. Drugs, on average, take 9.4 years from Phase I to approval in the allergy space.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for atopic dermatitis have been in the early and mid-phases of development, with 67% of trials in Phase I–II, and 33% in Phase III–IV.
- The US has a substantial lead in the number of atopic dermatitis clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
- Clinical trial activity in the atopic dermatitis space is dominated by completed trials. Novartis has the highest number of completed clinical trials for atopic dermatitis, with 74 trials.
- Novartis leads the industry sponsors with the highest overall number of clinical trials for atopic dermatitis, followed by Pfizer.
Table of Contents
OverviewKey TakeawaysEpidemiologyMarketed DrugsPipeline DrugsKey Upcoming EventsProbability of SuccessRevenue OpportunityAppendix
Disease Background
Treatment
Recent Events and Analyst Opinion
Key Regulatory Events
Licensing and Asset Acquisition Deals
Clinical Trial Landscape
Bibliography
List of Figures
List of Tables
