POLL: Which Anticipated Drug Approval/PDUFA Date Are You Most Looking Forward to in 2025?

The upcoming year is poised to bring significant advancements in dermatologic treatments, with 3 highly anticipated Prescription Drug User Fee Act (PDUFA) dates on the horizon. These therapies address pressing unmet needs in dermatology and promise to enhance patient care.

First, dupilumab (Dupixent) has the potential to become the first targeted therapy for chronic spontaneous urticaria in over a decade. Backed by strong data from the LIBERTY-CUPID clinical trials, Dupixent offers hope for patients struggling with uncontrolled itching and hives.¹

Next, prademagenezamikeracel (pz-cel) may revolutionize care for patients with recessive dystrophic epidermolysis bullosa, a rare and debilitating condition. The FDA's acceptance of Abeona Therapeutics’ resubmitted Biologics License Application puts this innovative gene therapy one step closer to addressing unmet needs in wound healing and pain management.²

Finally, roflumilast foam 0.3% (Zoryve) offers a steroid-free, easy-to-apply option for treating scalp and body psoriasis. Results from the ARRECTOR phase 3 trial highlight its potential to clear plaques and relieve symptoms in hair-bearing and other hard-to-treat areas.³

We want to hear from you. Which of these PDUFA dates are you most excited about, and why? Cast your vote in our poll below and share your thoughts with the Dermatology Times community.

Want to share more of your insights and perspectives with us? Email our team at DTEditor@mmhgroup.com.

References

1. Dupixent (dupilumab) sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria (CSU). News release. Regeneron. November 15, 2024. Accessed January 3, 2025. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-review-treatment-chronic
2. Abeona Therapeutics announces FDA accepts and grants Priority Review for pz-cel biologics license application (BLA). News release. Abeona Therapeutics. November 27, 2023. Accessed January 3, 2025. https://investors.abeonatherapeutics.com/press-releases/detail/268/abeona-therapeutics-announces-fda-accepts-and-grants
3. 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 January 3, 2025. 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/