Following the news that Arcutis Biotherapeutics announced that its roflumilast met its main endpoints in the Phase III trial INTEGUMENT-1 (NCT04773587) for atopic dermatitis (AD).

Ramla Salad, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“Following such a fantastic result, GlobalData expects Arcutis Biotherapeutics’ roflumilast to enter the US atopic dermatitis (AD) market by Q2 2024, followed by the 5EU* in Q2 2025. It is projected to bring the company total sales of $80 million by 2030.

“AD is a new avenue for Arcutis Biotherapeutics, which is expanding from its core focus of the psoriasis market. Roflumilast’s results are particularly significant due to the high prevalence of AD, with the mild-to-moderate group being the most underserved when it comes to pharmacological disease management.

“Safety is becoming a key differentiator among products for AD, and the INTEGUMENT-1 data indicates that roflumilast was well tolerated. This evidence will be crucial when competing against Eucrisa (crisaborole), another topical phosphodiesterase-4 (PDE4) inhibitor that is indicated for the treatment of mild-to-moderate AD in both adult and pediatric patients. Eucrisa is a highly established product with a strong safety and efficacy profile, as exemplified by the fact that it’s used in patients as young as three months. Thus, a stellar safety profile for roflumilast will be crucial for the product to gain market share within the PDE4 inhibitor space—particularly as Eucrisa approaches US patent expiry in 2026.

“Arcutis Biotherapeutics is also anticipating top-line results from a second pivotal trial, INTEGUEMENT-II (NCT04773600), for roflumilast by the end of 2022.”

* 5EU: France, Germany, Italy, Spain and the United Kingdom