For Immediate Release

September 28, 2018

Release

The U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease).（治疗由鸟型分枝杆菌（MAC）引起的肺部疾病，该疾病患者人数有限，罕见病药物）

MAC is a type of nontuberculous mycobacteria (NTM) commonly found in water and soil. Symptoms of disease in patients with MAC include persistent cough, fatigue, weight loss, night sweats, and occasionally shortness of breath and coughing up of blood.

“As bacteria continue to grow impervious to currently available antibiotics, we need to encourage the development of drugs that can treat resistant infections. That means utilizing novel tools intended to streamline development and encourage investment into these important endeavors,” said FDA Commissioner Scott Gottlieb, M.D. “This approval is the first time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and it marks an important policy milestone. This pathway, advanced by Congress, aims to spur development of drugs targeting infections that lack effective therapies. We’re seeing a lot of early interest among sponsors in using this new pathway, and it’s our hope that it’ll spur more development and approval of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.”

FDA新药速递：阿米卡星脂质体吸入混悬液昨日获批

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622048.htm

附：

截止9月29日，FDA批准了42款药物。

其中FDA批准34款新药，截止2018年8月30日

Novel Drug Approvals for 2018，Update to 8/30/2018

FDA新药速递：阿米卡星脂质体吸入混悬液昨日获批

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA). For instance, new information may become available which could lead to a reconsideration of the original designation or status. If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.（FDA是动态及时更新新分子实体或者生物药、疫苗等获批情况）

参考：

NMPA/CDE；

药融数据，Pharnex Datamonitor;