加拿大Valeant製藥於昨日(6月9日)宣布，其研發的三唑類抗真菌藥物 Jublia(efinaconazole)已獲得美國FDA批準上市，用於治療遠端側位甲下型甲真菌病(DLSO，最為常見的甲真菌病亞型)。Jublia為外用劑型，通過特殊裝置塗抹在受累指甲處，可有效避免抗真菌藥物的全身性不良作用。
新聞來源: Valeant Pharmaceuticals Announces FDA Approval Of Jublia® for the Treatment of Onychomycosis
Information about Jublia(®) (efinaconazole 10% topical solution)
Jublia(®) (efinaconazole 10% topical solution), is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).
Being a solution, Jublia(®) is applied daily to the nail with a novel bottle that has a built-in flow-through brush applicator. It dries quickly and there is no need to remove excess product. There are no concerns for systemic side effects such as drug-drug interactions or acute liver injury.
Jublia(®) has been extensively studied prior to its approval. The two positive pivotal studies that were the basis for approval were published last year in the prestigious Journal of the American Academy of Dermatology. These international studies were conducted in 1,655 subjects with onychomycosis, including subjects in Canada.
For the pivotal studies, the primary endpoint was complete cure at Week 52, which required that the target nail show no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with Jublia® were completely cured, compared to only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with Jublia(®) were completely cured, compared to only 5.5% of subjects treated with vehicle.
Adverse events that were reported were generally mild and transient and were similar between subjects treated with Jublia(®) and vehicle. The most commonly reported adverse events in patients treated with Jublia(®) were application site dermatitis and application site vesicles.
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