Elanco's Dermatology Treatment Secures FDA Approval For Itchy Dogs, Analyst Highlights Label Warnings And Efficacy
Elanco's Dermatology Treatment Secures FDA Approval For Itchy Dogs, Analyst Highlights Label Warnings And Efficacy
Elanco conducted a head-to-head noninferiority study comparing the efficacy and safety of Zenrelia and Apoquel for submission in the European Union.On Thursday, the FDA approved Elanco Animal Health Incorporated's (NYSE:ELAN) Zenrelia, a once-daily oral JAK inhibitor for the control of pruritus (itching) associated with allergic dermatitis and atopic dermatitis in dogs at least 12 months of age.
週四，美國食品藥品監督管理局批准了Elanco Animal Health Incorporated（紐交所:ELAN）的Zenrelia，這是一種每天一次的口服JAk抑制劑，用於控制至少12個月大的犬科過敏性皮炎和特應性皮炎相關的瘙癢（瘙癢）
Approximately 17 million dogs suffer from allergic skin disease, including atopic dermatitis, food allergies, or flea sensitivity.
約有1700萬隻狗患有過敏性皮膚病，包括特應性皮炎、食物過敏或跳蚤敏感性皮膚炎。
Also Read: Elanco Animal Health Shares Sink On Unexpected Label Update For Canine Dermatology Drug.
另請閱讀：意外的標籤更新導致Elanco Animal Health股價下跌，這是一種用於犬科皮膚病治療的藥品。
Elanco conducted a head-to-head noninferiority study comparing the efficacy and safety of Zenrelia and Apoquel for submission in the European Union.
Elanco進行了一項頭對頭非劣性研究，比較了Zenrelia和Apoquel的功效和安全性，以便提交給歐盟
A study of 338 client-owned dogs with confirmed atopic dermatitis was conducted.
對338只已確診爲特應性皮炎的客戶狗進行了一項研究。
The study shows one daily dose of Zenrelia is at least as effective as the market incumbent JAK inhibitor at the primary endpoint on Day 28.
研究顯示，Zenrelia每日一次的劑量在主要終點日（第28天）至少與市場上的JAk抑制劑一樣有效。
- Zenrelia provided consistently greater relief from itch and skin lesions over time, with once-daily dosing from the start, while rebound itch was observed in Zoetis Inc's (NYSE:ZTS) Apoquel (oclacitinib)-treated dogs after dosing decreased to once daily after Day 14.
- 77% of Zenrelia-treated dogs achieved clinical remission of itch, compared to 53% of Apoquel-treated dogs.
- Zenrelia從一開始每日一次給藥，持續提供了更加持久的瘙癢和皮膚損傷緩解，而在Zoetis Inc（紐交所:ZTS）的Apoquel（oclacitinib）治療的狗每日一次給藥後，瘙癢反彈。該情況在第14天后給藥減少到每日一次後觀察到。
- 77%接受Zenrelia治療的狗實現了瘙癢的臨床緩解，而53%的Apoquel治療的狗實現了臨床緩解。
William Blair highlights that Zenrelia's label includes a warning advising discontinuation 28 days to 3 months before any vaccination. This raises concerns about whether veterinarians will readily adopt the new skin product, given the extra precautions needed, especially considering some dogs receive vaccines as frequently as once a year.
William Blair指出，Zenrelia的標籤包含警告，建議在任何疫苗注射前28天至3個月停止使用。這引發了獸醫是否會願意採用這種新的皮膚產品的擔憂，尤其考慮到一些狗犬每年需要接種疫苗的頻率。
In reviewing the clinical data, it was noted that the placebo effect in Zenrelia's FDA study was significantly higher than in Apoquel's, suggesting that Apoquel's actual impact on atopic dermatitis may be more robust than Zenrelia's.
在審查臨床數據時，注意到Zenrelia在FDA研究中的安慰劑效應顯著高於Apoquel's，這表明Apoquel對特應性皮炎的實際影響可能比Zenrelia更加強大。
This raises doubts about Zenrelia's true efficacy in comparison. Additionally, William points out that adverse events, such as diarrhea and vomiting, occurred at twice the rate in Zenrelia's FDA study than in Apoquel's.
這引發了對Zenrelia真實療效的懷疑。此外，William指出在Zenrelia的FDA研究中，腹瀉和嘔吐等不良事件發生率是Apoquel的兩倍。
The analyst notes that investor expectations for Zenrelia over the next two years are already elevated. However, due to lingering uncertainties, William prefers to wait for concrete execution before assessing if it can sustainably impact the P&L statement. The analyst maintained the Market Perform rating.
分析師指出，對Zenrelia未來兩年的投資者預期已經相當高。然而，由於存在持續的不確定性，William更願意等待具體的執行情況，然後評估其是否能夠持續影響利潤和損益表。分析師維持市場表現評級。
Price Action: ELAN stock traded lower by 4.18% at $14.44 at the last check Friday.
股價走勢：ELAN股價在上週五最新檢查時下跌了4.18%，報14.44美元。
Image via Unsplash
圖片來源：Unsplash
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譯文內容由第三人軟體翻譯。