FDA Anticipated to Decide on Dupixent, Pz-cel, and Roflumilast Foam for Dermatologic Conditions by Mid-2025
Key Insights
The FDA is reviewing Dupixent for chronic spontaneous urticaria (search), with a PDUFA date of April 18, 2025, potentially offering a novel targeted therapy after a decade of limited options.
Abeona Therapeutics' pz-cel for recessive dystrophic epidermolysis bullosa (search) has a resubmitted BLA with a PDUFA date of April 29, 2025, following a Complete Response Letter earlier in 2024.
Arcutis Biotherapeutics' roflumilast foam for scalp and body psoriasis (search) has a PDUFA date of May 22, 2025, offering a steroid-free alternative for hard-to-treat areas.
The FDA is expected to make decisions on several key dermatologic treatments by mid-2025, including Dupixent for chronic spontaneous urticaria (search), pz-cel for recessive dystrophic epidermolysis bullosa (search), and roflumilast foam for scalp and body psoriasis (search). These potential approvals could significantly impact the treatment landscape for these conditions.
Dupixent for Chronic Spontaneous Urticaria
Sanofi and Regeneron are awaiting the FDA's decision on their supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) in treating uncontrolled chronic spontaneous urticaria (search) (CSU), with a Prescription Drug User Fee Act (PDUFA) goal date of April 18, 2025. If approved, Dupixent would be the first targeted therapy for CSU in over 10 years. The sBLA is supported by positive results from the phase 3 LIBERTY-CUPID clinical trials. In Study C, nearly half of patients treated with dupilumab reached well-controlled disease status and saw a significant reduction in itching and hives.
"These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease," said Dr. Thomas B. Casale, professor of Internal Medicine at the Morsani College of Medicine at the University of South Florida.
Pz-cel for Recessive Dystrophic Epidermolysis Bullosa
Abeona Therapeutics is also anticipating an FDA decision on its Biologics License Application (BLA) for pz-cel (prademagenezamikeracel), an investigational autologous, COL7A1 (search) gene-corrected epidermal sheet, for recessive dystrophic epidermolysis bullosa (search). The FDA has set a new PDUFA date of April 29, 2025, after accepting the resubmitted BLA. The initial BLA received a Priority Review based on positive data from the pivotal phase 3 VIITAL study and the phase 1/2a study. These studies demonstrated that a single application of pz-cel to large, chronic wounds resulted in sustained wound healing and pain reduction for patients with RDEB. However, the FDA issued a Complete Response Letter (CRL) in April 2024, citing the need for additional Chemistry Manufacturing and Controls information before approval. The resubmission addresses these concerns.
"The FDA acceptance of our BLA resubmission moves us one step closer to providing pz-cel as a differentiated treatment option to address the persistent unmet needs of people with RDEB in the US," said Vish Seshadri, chief executive officer of Abeona.
Roflumilast Foam for Scalp and Body Psoriasis
Arcutis Biotherapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for roflumilast foam 0.3% (Zoryve) for the treatment of both scalp and body psoriasis (search), with a PDUFA date of May 22, 2025. This formulation aims to address the challenges of applying traditional creams and ointments to areas with hair. The sNDA is supported by positive results from the pivotal ARRECTOR phase 3 trial and a phase 2b study, along with long-term efficacy and safety data from the roflumilast development program. The ARRECTOR study, a double-blind, vehicle-controlled trial, evaluated the safety and efficacy of roflumilast foam 0.3% in individuals with scalp and body psoriasis aged 12 and older. The study involved 432 participants and met its co-primary endpoints.
"Hair-bearing areas present unique treatment challenges that are not easily addressed with creams or ointments. Individuals with plaque psoriasis need steroid-free treatment options that clear plaques anywhere on the body and relieve burdensome symptoms, such as itch and flaking," said Dr. Melinda Gooderham, medical director of the SKiN Centre for Dermatology and a clinical trial investigator.