Looking Ahead to 2025 Dermatology Drug Approvals

Review our list below of dermatology Prescription Drug User Fee Act (PDUFA) goal dates to keep on your dermatologic radar this upcoming year.

April 18, 2025: Dupilumab (Dupixent; Sanofi) for Chronic Spontaneous Urticaria

In November, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the US Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) in treating uncontrolled chronic spontaneous urticaria (CSU).¹ If approved, this would be the first targeted therapy for CSU in over 10 years.

The resubmission is supported by positive results from the phase 3 LIBERTY-CUPID clinical trials (Study A, Study B, and Study C). In the latest phase of the trial, Study C, investigators found nearly half of patients treated with dupilumab reached well-controlled disease status and saw a significant reduction in itching and hives.²

In a press release, Thomas B. Casale, MD, professor of Internal Medicine at the Morsani College of Medicine at the University of South Florida, said, "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.”²

April 29, 2025: Pz-cel (prademagenezamikeracel) (Abeona Therapeutics) for Recessive dystrophic epidermolysis bullosa

In November of last year, the FDA granted Priority Review for Abeona's Biologics License Application (BLA) for the investigational autologous, COL7A1 gene-corrected epidermal sheets and established a target Prescription Drug User Fee Act (PDUFA) date of May 25, 2024.³

The acceptance of the BLA for Priority Review was based on positive data from the pivotal phase 3 VIITAL study (NCT04227106) and additional confirmation from the phase 1/2a study (NCT01263379). These studies showcased that applying pz-cel once to large and chronic wounds consistently resulted in sustained wound healing and pain reduction for patients with RDEB.³

However, in April of this year the FDA issued a Complete Response Letter (CRL) indicating that the timing proposed for data submission would not allow enough time for the organization to finish its review by the target date. The administration identified the need for additional information to fulfill Chemistry Manufacturing and Controls requirements before granting approval. Specifically, the CRL highlighted specific validation requirements for certain manufacturing and release testing methods, including those observed during the FDA's pre-license inspection.

Finally in November, Abeona announced that the FDA had accepted its resubmitted BLA for the drug under this indication, establishing a new PDUFA date of April 29, 2025.⁴

"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, in a news release.⁵ "We look forward to continuing to work with the FDA to finalize the review of the pz-cel application."

May 22, 2025: Roflumilast foam 0.3% (Zoryve; Arcutis Biotherapeutics) for scalp and body psoriasis

In July of this year, Arcutis Biotherapeutics submitted a supplemental New Drug Application (sNDA) to the FDA for roflumilast cream 0.3% for the treatment of both scalp and body psoriasis. Traditional creams and ointments are often difficult to apply effectively in areas with hair, necessitating alternative treatment options.⁶

The submission to the FDA is supported by positive results from the pivotal ARRECTOR phase 3 trial (NCT05028582) and a phase 2b study, alongside long-term efficacy and safety data from the roflumilast development program. The ARRECTOR study, a double-blind, vehicle-controlled pivotal phase 3 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 with impressive results.⁷

Melinda Gooderham, MD, MSc, FRCPC, medical director of the SKiN Centre for Dermatology and a clinical trial investigator, highlights the unique treatment challenges posed by scalp psoriasis. "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," she said in a press release. The investigational roflumilast foam, she noted, effectively clears both scalp and body psoriasis, as demonstrated in clinical trials.

References

1. Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU). News release. Regeneron. November 15, 2024. Accessed December 17, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-review-treatment-chronic
2. Dupixent® (dupilumab) late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI. News release. Regeneron. October 24, 2024. Accessed December 17, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-late-breaking-positive-phase-3-data-chronic
3. Abeona Therapeutics announces FDA accepts and grants Priority Review for pz-cel biologics license application (BLA). News release. Abeona Therapeutics. November 27, 2023. Accessed December 17, 2024. https://investors.abeonatherapeutics.com/press-releases/detail/268/abeona-therapeutics-announces-fda-accepts-and-grants
4. Abeona Therapeutics provides regulatory update on pz-cel. News release. Abeona Therapeutics. April 22, 2024. Accessed December 17, 2024. https://investors.abeonatherapeutics.com/press-releases/detail/276/abeona-therapeutics-provides-regulatory-update-on-pz-cel
5. Abeona Therapeutics announces FDA acceptance of BLA resubmission of Pz-cel for the treatment of recessive dystrophic epidermolysis bullosa. News release. Globe Newswire. November 12, 2024. Accessed December 17, 2024. https://www.globenewswire.com/news-release/2024/11/12/2978973/0/en/Abeona-Therapeutics-Announces-FDA-Acceptance-of-BLA-Resubmission-of-Pz-cel-for-the-Treatment-of-Recessive-Dystrophic-Epidermolysis-Bullosa.html
6. Arcutis submits supplemental new drug application for ZORYVE® (roflumilast) foam to the FDA for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over. News release. Arcutis Biotherapeutics, Inc. July 23, 2024. Accessed December 17, 2024. https://www.arcutis.com/arcutis-submits-supplemental-new-drug-application-for-zoryve-roflumilast-foam-to-the-fda-for-the-treatment-of-scalp-and-body-psoriasis-in-adults-and-adolescents-ages-12-and-over/
7. Bader K. Arcutis presents positive roflumilast foam data from ARRECTOR trial in scalp and body PSO at EADV. Dermatology Times. October 13, 2023. Accessed December 17, 2024. https://www.dermatologytimes.com/view/arcutis-presents-positive-roflumilast-foam-data-from-arrector-trial-in-scalp-and-body-pso-at-eadv