Dermatology Times is reviewing some of the most anticipated PDUFA dates of the upcoming year.
Review our list below of dermatology Prescription Drug User Fee Act (PDUFA) goal dates to keep on your dermatologic radar this upcoming year.
In March of last year, Checkpoint announced that their Biologics License Application (BLA) for cosibelimab was under review by the US Food and Drug Administration (FDA) with an anticipated PDUFA date of January 3.
However, on December 18, Checkpoint announced that they now face a delay in the approval process for its cosibelimab BLA following the issuance of a complete response letter (CRL) by the FDA.
The CRL specifically points to issues uncovered during an FDA inspection of Checkpoint's third-party contract manufacturing organization.
Notably, no concerns were raised regarding clinical data, safety, or labeling.
James Oliviero, President and CEO of Checkpoint, remains optimistic, stating that the company aims to address the deficiencies in a resubmission, anticipating marketing approval for cosibelimab in 2024.
The US FDA accepted Novan Inc.’s New Drug Application (NDA) filing for berdazimer gel, 10.3% for the treatment of molluscum contagiosum in March.
Novan submitted its NDA to the FDA in January 2023. The NDA submission was based on positive data from the phase 3 study of berdazimer gel, 10.3%, B-SIMPLE4 (NCT04535531).
Berdazimer gel demonstrated statistically significant improvement in the primary endpoint of complete clearance of all treatable molluscum contagiosum at week 12. Berdazimer gel was reported to be well tolerated with mild application site pain and mild-to-moderate erythema reported as the most common adverse event.
Iovance Biotherapeutics is currently seeking approval for the one-time tumour-infiltrating lymphocyte therapy as a second-line of treatment for patients with advanced melanoma, following the initiation of anti-PD-1/L1 inhibitors and targeted therapies.
With an initial PDUFA date of November 25, 2023, Iovance announced in September that the date had been pushed back to February 24, 2024 as a result of an FDA backlog.
At the time of the announcement, Iovance noted that no major issues with the review or the status of the confirmatory trial were cited.
Abeona Therapeutics announced in November that the FDA had accepted and granted Priority Review for its BLA for pz-cel (prademagene zamikeracel), investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB).
The FDA’s acceptance of the BLA is based on the clinical efficacy and safety data from the pivotal phase 3 VIITAL study (NCT04227106) and additional confirmatory data from the phase 1/2a study (NCT01263379). Both studies demonstrated that a one-time application of pz-cel on large and chronic wounds delivered sustained wound healing and pain reduction for patients with RDEB.
The US FDA accepted a Supplemental New Drug Application (sNDA) from Arcutis for roflumilast cream 0.15% for the treatment of atopic dermatitis (AD) in both adults and children as young as 6 years of age in November.
The sNDA is supported by positive safety and efficacy data from 3 phase 3 programs, including INTEGUMENT-1 and INTEGUMENT-2, a phase 2 dose-ranging study, and 2 phase 1 studies assessing the pharmokinetics of the drug.
Patients treated with roflumilast met the primary end point of validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) success at a rate much higher than among patients receiving the placebo. 32.0% of patients treated with roflumilast achieved vIGA-AD success compared to a rate of 15.2% in the vehicle control group at week 4 in INTEGUMENT-1. In INTEGUMENT-2, the same held true with 28.9% of patients receiving roflumilast achieving vIGA-AD compared to a rate of 12.0% in the vehicle control group, also at week 4.
Both studies also met a key endpoint of Eczema Area and Severity Index (EASI) reduction, with more than 40% of patients treated with roflumilast achieving a 75% reduction in EASI (EASI-75) by week 4 compared with patients treated with the vehicle control (22% and 19.7% in INTEGUMENT-1 and 2, respectively).
Roflumilast cream 0.15% was well-tolerated in patients with low incidence of treatment-emergent adverse events being low and predominantly mild to moderate in nature.