CDER-Approved NDA for SCENESSE® (afamelanotide 16mg)
On October 8, 2019, the FDA granted approval to Clinuvel Pharmaceuticals Limited’s SCENESSE® (afamelanotide 16mg) implant, to prevent painful skin damage from the sun in adult patients with a history of a rare metabolic disorder—phototoxic reactions from erythropoietic protoporphyria (EPP). Key findings from the FDA’s Multi-Discipline Review:
- While the real-world evidence (RWE) didn’t establish safety or effectiveness of afamelanotide for the FDA, it supported the safety information obtained from the clinical trials.
- A randomized, placebo-controlled study (CUV039) provided evidence of efficacy.
- In the FDA’s review of the safety database, it included all randomized subjects from patients in phase 3 trials (CUV029, CUV030, and CUV039) who received at least one study implant. “Therefore, the safety database presented by the Applicant is sufficient [for the FDA] to characterize the safety of afamelanotide...”
- Clinuvel’s corporate annual report showed that the safety profile of SCENESSE, based on the PASS, was unchanged compared to the official product information.
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