加拿大Valeant制药于昨日(6月9日)宣布，其研发的三唑类抗真菌药物 Jublia(efinaconazole)已获得美国FDA批准上市，用于治疗远端侧位甲下型甲真菌病(DLSO，最为常见的甲真菌病亚型)。Jublia为外用剂型，通过特殊装置涂抹在受累指甲处，可有效避免抗真菌药物的全身性不良作用。
新闻来源: 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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如需要，接受医生诊疗时，不妨问问这个新药的信息。
