Regeneron and Sanofi have announced the FDA approval of Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately managed by topical therapies or in patients in whom those therapies are not recommended. Dupixent is a human monoclonal antibody that specifically binds to interleukin (IL) 4 receptor alpha (IL-4RA), which is involved in both IL-4- and IL-13-mediated effects that play a central role in numerous type-2 mediated disease, including AD, asthma, eosinophilic esophagitis, and nasal polyps. Dupixent is the first biologic to gain approval for AD, giving it market exclusivity for an initial targeted population of approximately 300,000 patients—a significant opportunity for Regeneron and Sanofi.
The FDA approval of Dupixent was based on the global LIBERTY AD clinical program, which encompassed three randomized pivotal Phase III trials (SOLO 1, SOLO2, and CHRONOS) enrolling 2,119 adult patients with inadequately controlled moderate-to-severe AD. In SOLO 1 and 2, 38 percent and 36 percent of patients receiving Dupixent (300mg every two weeks) achieved clear or almost clear skin at week 16, the primary endpoint, as measured by the 5-point Investigators Global Assessment (IGA) scale, compared with 10 percent and 9 percent of patients receiving placebo, respectively. In CHRONOS, 39 percent of patients receiving Dupixent with topical corticosteroids (CS) achieved the primary endpoint, clear or almost clear skin (IGA 0 or 1), compared with 12 percent of patients receiving placebo with topical CS. In addition, at week 52, 36 percent of patients receiving Dupixent with topical CS achieved IGA 0 or 1 compared with 13 percent receiving placebo with topical CS, demonstrating a significant improvement in overall disease severity at both week 16 and 52.
Dupixent was granted Breakthrough Therapy Designation by the FDA in 2014, which was followed by Priority Review, both of which are reserved for therapies with the potential to significantly improve the treatment of a life-threatening or neglected disease, accelerating the development and approval process. Dupixent was approved as a pre-filled syringed to be administered as a 300mg subcutaneous injection every two weeks, after an initial loading dose of 600mg. The Wholesale Acquisition Cost of Dupixent is $37,000 annually, a price point that is justified by the drug’s first-in-class status as a biologic for AD, the serious disease burden and unmet need in the AD space, Dupixent’s significant clinical benefit over current treatment options, and the price of biologics for the treatment of psoriasis. Sanofi and Regeneron anticipate the actual cost to payers and health care systems will be in the low $30,000 range upon application of rebates, discounts, and patient assistance programs.
GlobalData expects immediate access to Dupixent for AD patients, as Sanofi and Regeneron are initially targeting approximately 7,000 physicians in the US already familiar with biologics, including dermatologists who prescribe biologics for the treatment of psoriasis as well as allergists/immunologists who commonly prescribe biologics for asthma and other inflammatory diseases. Given the Phase III development of Dupixent in asthma and eosinophilic esophagitis, GlobalData anticipates that Sanofi and Regeneron’s strategy to target allergists and immunologists will position Dupixent for strong uptake in these indications upon launch, given the specialists’ familiarity with the drug. Despite additional approvals, Dupixent is slated for success in the adult AD market as a revolutionary treatment of an otherwise debilitating disease.
GlobalData (2015). PharmaPoint: Atopic Dermatitis – Global Drug Forecast and Market Analysis to 2024, November 2015, GDHC120PIDR
GlobalData (2014). PharmaPoint: Asthma – Global Drug Forecast and Market Analysis to 2023, August 2014, GDHC83PIDR
GlobalData (2016). PharmaPoint: Psoriasis –Drug Forecast and Market Analysis to 2024, April 2016, GDHC119PIDR