近日，美国食品和药物管理局（FDA）批准MOXIDECTIN(Moxidectin 中文药名：莫昔克丁)口服药，用于治疗12岁及以上患者的河盲症（盘尾丝虫病）。
批准日期 2018年6月13日 持证商：Medicines Development Limited
MOXIDECTIN（莫昔克丁 MOXIDECTIN）片剂，口服使用
美国最初批准：2018年
作用机制
莫昔克丁是一种大环内酯，是一种驱虫药[见微生物学]。
适应症和用法
莫昔克丁是一种驱虫药，适用于治疗12岁及以上患者因Onchocerca volvulus引起的盘尾丝虫病。
使用限制：
•Moxidectin片剂不会杀死成年O. volvulus寄生虫。建议进行后续处理。
•重复给予莫昔克丁的安全性和有效性尚未研究患有O.volulus的患者的片剂。
剂量和给药
12岁及以上的患者：服用8毫克（4片 2毫克片剂）单剂量口服，含或不含食物。
剂量形式和强度
片剂：2毫克。
禁忌症
没有。
警告和注意事项
•不同严重程度的皮肤，眼科和/或全身不良反应（Mazzotti反应）：这可能发生在患有盘尾丝虫病的患者中，接着用盐酸盐片剂治疗。监测患者的症状，包括症状性体位性低血压。
•症状性直立性低血压：症状性原发性低血压的发作，包括无法与使用MoxidectinTablets治疗后患者的支持。
•Loa loa合并感染患者的脑病：使用Moxidectin平板治疗后严重或偶发性脑病可能发生在与Loa loa共同感染的患者中。在治疗前评估Loa loa流行地区的患者肛门疾病。
•水肿和恶性皮肤炎：恶性反应性皮炎（sowda）患者可能比其他人更容易出现严重的水肿和恶性皮炎。
不良反应
最常见的不良反应（发生率> 10％）是：嗜酸性粒细胞增多，瘙痒，肌肉骨骼疼痛，头痛，淋巴细胞减少，心动过速，皮疹，腹痛，低血压，发热，白细胞增多，流感样疾病，中性粒细胞减少，咳嗽，淋巴结疼痛，头晕，腹泻，低钠血症和周围肿胀。
要报告疑似不良反应，请致电1-800-MDGH-456联系Medines Development for Global Health，或联系1-800-FDA-1088或www.fda.gov/medwatch联系.FDA。
如何提供/存储和处理
含有2毫克莫昔克丁的莫昔克丁片剂为白色至淡黄色未包衣的椭圆形片剂，一边用“AKKA”压制。 每个高密度聚乙烯瓶含有500片
（NDC 71705-050-01），硅胶干燥剂和聚酯线圈。
储存温度低于30°C（86°F）。
•避光。
•一旦打开，容器的全部内容应在24小时内使用，并包含任何未使用的内容
丢弃。
FDA Approves New Treatment for Onchocerciasis
The Food and Drug Administration (FDA) has approved moxidectin for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients ≥12 years of age.
Moxidectin, a macrocyclic lactone, is an anthelmintic drug that selectively binds to the parasite's glutamate-gated chloride ion channels. It is active against O. volvulus microfilariae but it does not kill adult O. volvulus parasites. The tropical disease spreads from person to person via black flies that breed near rivers in South and Central America, sub-Saharan Africa and Yemen.
The approval was based on data from two, randomized, double-blind, active-controlled trials in patients with O. volvulus infection (Trial 1: 1472 patients; Trial 2: a dose-ranging trial). Efficacy was assessed by skin microfilarial density from the mean of 4 skin snips per person per time point up to 18 months post-treatment. Treatment with moxidectin was found to be significantly superior to ivermectin (the current standard of care) in suppressing the presence of the microfilariae in skin.
The most common adverse reactions (incidence >10%) in clinical trials included eosinophilia, pruritus, musculoskeletal pain, headache, lymphopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, lymph node pain, dizziness, diarrhea, hyponatremia and peripheral swelling.
Moxidectin was developed through a partnership between the not-for-profit social enterprise Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR). "Achieving FDA approval is a critically important milestone for moxidectin, but our work to bring this medicine to those who need it most continues in earnest," said Mark Sullivan, Founder and Managing Director of MDGH.
Moxidectin is available in 2mg tablets. The safety and efficacy of repeat administration in patients with O. volvulus has not been studied.
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MOXIDECTIN(Moxidectin Tablets)
description
Drug Name: MOXIDECTIN
NDC: 71705-050-01
Active substance: MOXIDECTIN
Dosage: 2MG
Dosage form: TABLE
Market Status: Prescription
TE code: None
RLD: No
RS: No
Indications: Onchocerciasis, River Blindness
Licensee: Medicines Development Limited
Licensee Address: 261 Madison Avenue, 24th Floor
New York, NY 10016
Time to market: 06/13/2018
Whether dead orphan drugs: yes
Application No.: NDA 210867
Approval letter file:
Instructions:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210867lbl.pdf