FDA批准灰指甲外用新藥Jublia

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作者：tomato 來源：生物穀 2014-6-10 9:04:42 下載生物穀資訊App
Jublia是一種外用溶液，通過一種獨特的內寘用量控制型指甲刷進行涂敷，該藥能很快乾燥，無需出去過量的藥物，同時無需顧慮係統性副作用，如藥物相互作用或急性肝損傷。


Jublia是首個外用三唑類抗真菌藥，開發用於侷部遠端側位甲下甲真菌（DLSO）的治療，這是一種最為常見的甲真菌病，緻病菌先侵入遠端甲下甲床，甲床下角質增生、增厚，甲板可變為白色、棕色至灰褐色，表面凹凸不平，失去光澤，甲板缺失、松脆。

The condition typically begins as a small white or yellow spot beneath the nail, and causes nail discoloration, thickening and/or distortion, pain, detachment of the nail from the nail bed and irregular surface changes. Once onychomycosis begins, it can persist indefinitely if not treated and may cause permanent nail damage. Currently 85 percent of onychomycosis patients are untreated.

英文原文：Valeant Pharmaceuticals Announces FDA Approval Of Jublia® for the Treatment of Onychomycosis

Jublia® (efinaconazole 10% topical solution), is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).
灰指甲（onychomycosis）是一種發生在人指（趾）甲上的傳染性疾病的俗稱，是由一大類稱做病原真菌的微生物感染引起，該病目前治療不足，很大程度上是由於現有治療藥物的侷限性。目前，非處方或處方外用藥提供的療傚十分有限，在用藥的同時往往需要頻繁清創，或刮、切割或去除指甲。處方口服藥則由於藥物相互作用和嚴重的安全性問題而應用十分有限。
LAVAL, Quebec, June 9, 2014 /CNW/ - Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Jublia® (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails.
Onychomycosis is a common and destructive nail infection that is currently undertreated largely because of the limitations of available treatments. Currently, over-the-counter or prescription topical treatments provide limited efficacy and are often administered in conjunction with frequent debridement, or the scraping, cutting or removal of the nail. Prescription oral treatments are limited by drug interactions and serious safety concerns.
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.
Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi that typically occurs under the toenail,汽車借款, though fingernails may also be affected. Approximately 35 million Americans suffer from onychomycosis, most of whom are men between 50 and 70 years of age. The fungi that cause onychomycosis live in warm, moist environments, including swimming pools and showers, and may invade the skin through tiny cuts or small separations between the nail and nail bed.
關於Jublia（efinaconazole,桃園機車借款免留車，10%外用溶液）：

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.
"We acquired Jublia® through our purchase of Dow Pharmaceutical Sciences in 2008 and advanced Jublia® from pre-IND stage through Clinical Phases 1, 2 and 3," said J. Michael Pearson, chairman and chief executive officer. "We are working quickly to get this important product launched in the U.S. and Canada in the third quarter of 2014. We anticipate favorable managed care coverage in the U.S., similar to other branded antifungal agents, with peak sales of $300-$800 million in the U.S. alone and we are also working with other regulatory agencies around the world on further approvals. This is the fourth product, sourced from our acquisition of Dow Pharmaceutical Sciences, for which we have received FDA approval – the other three being 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya® and Retin-A Micro (tretinoin) Gel microsphere 0.08%. We have also filed a new treatment for acne, Onexton™, which has a PDUFA date of November 30, 2014. All these compounds came through our Dow acquisition, bringing with it the full set of R&D capabilities from preclinical through regulatory."

(責任編輯：lishuheng)



The licensor and business partner for efinaconazole, Kaken Pharmaceutical, has also agreed to supply Valeant with the finished dosage form of Jublia for the U.S. market.



2014年6月9日訊 /生物穀BIOON/ --加拿大Valeant制藥6月9日宣佈,台中汽車借款，旂下Valeant制藥北美子公司抗真菌藥Jublia（efinaconazole，10%外用溶液）獲FDA批准，用於腳趾甲灰指甲（onychomycosis）的治療，該藥是首個外用三唑類（trizole）抗真菌藥物。此前，Jublia於2013年11月獲加拿大衛生部批准。Valeant計劃於2014年第三季度在美國和加拿大推出該藥。Jublia在美國的銷售峰值預計為3-8億美元。
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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.
"Onychomycosis is not only embarrassing and uncomfortable, but can lead to permanent nail damage and limited mobility in the general population," said American Podiatric Medical Association Executive Director and CEO Glenn B. Gastwirth, DPM. "We welcome the approval of Jublia® and encourage people with onychomycosis of the toenails to discuss their condition with their podiatrist, or other healthcare professional to find a treatment that's right for them."


關鍵詞：Valeant,灰指甲,Jublia,efinaconazole
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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.

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