Arcutis Biotherapeutics recently announced the submission of a New Drug Application (NDA) for its topical phosophodiesterase 4 (PDE4) inhibitor, roflumilast, in the treatment of mild-to-severe plaque psoriasis (PsO). Despite having a potential commercial advantage as the first branded topical therapy for an underserved PsO patient subgroup, GlobalData, a leading data and analytics company, notes that Arcutis may still face several challenges when marketing roflumilast.
Tiffany Chan, Immunology Analyst at GlobalData, comments: “Over the last decade, the PsO pipeline has been dominated by injectable biologics targeting moderate and severe disease, while topical therapies have strikingly lacked innovation. If approved by the FDA, roflumilast would become the second PDE4 inhibitor to enter the PsO market (after Amgen’s Otezla) and the first topical PDE4 inhibitor for the disease.”
The company’s NDA submission is based on two pivotal Phase III studies, DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389). Roflumilast, as a molecule, is already approved in oral tablet form (500mg) for chronic obstructive pulmonary disease (COPD), under the brand name Daliresp, which is currently marketed by AstraZeneca. The topical form by Arcutis is currently in development for PsO as well as atopic dermatitis.
Ms. Chan continues: “One challenge Arcutis faces is that it’s not only a newcomer to the mature PsO market, but to the pharma market as a whole—topical roflumilast would represent the company’s first marketed asset for any indication. Although the company’s reputation (or lack thereof) is not expected to impede the regulatory decisions, the company may have a slower process of contracting with payers. If the company were to partner with a more established player in the space such as AbbVie, Pfizer, or Janssen, it could expand its reach and obtain a stronger foothold in the market.
“Additionally, roflumilast is expected to be the first of two innovative branded topical therapies approved in the near future. Key opinion leaders interviewed by GlobalData anticipated that roflumilast will be directly competing with Dermavant’s topical arylhydrocarbon receptor (Ahr) agonist, tapinarof, for use in mild and moderate PsO patients. Although there is impending competition, roflumilast’s first-to-market advantage is expected to give it leverage in the market against its competitors.”
Roflumilast and the other late-stage PsO pipeline agents (both topical and oral) signal a changing of the guard in terms of market development. Primary research conducted by GlobalData indicates that given the options of oral, subcutaneous, and topical therapies, PsO patients generally prefer topical therapies (followed by oral) and it appears that drug manufacturers are finally moving away from the biologic focus of the last decade to meet this remaining need. Historically, much of the clinical and research focus has been on treating the most severe patients but roflumilast and other newer drugs will finally address milder populations, which have been somewhat neglected until now.