Analysis of orphan drugs approved by FDA in 2015

WANG Li; LIANG Yue-qin; XU Hong

Abstract：Objective:To make a statistical analysis of the general situation of orphan drugs approved by FDA in 2015,focusing on the mechanism research and development of orphan drugs and representative drugs in the field of three major hot spots,to let more medical personnel understand the development of orphan drugs in recent years and provide information for our medical profession.Methods:By searching Drugs@FDA database and literature,etc,the information about the drugs approved by the FDA in 2015 was collected,and analysis was carried out for the orphan drugs.Results:FDA approved a total of 45 novel drugs in 2015,among which there were 21 orphan drugs,including 12 new molecular entities and 9 biological products.The number of approval was the highest among recent years.The hot spots in the research field included anti-tumor,cardiovascular,anti infection drugs.The orphan drugs approved in 2015 in the three areas occupied a certain proportion,at a ratio of 11 ∶ 1 ∶ 1.Conclusion:The research and development of orphan drugs are booming in foreign countries.Our country need to do more in this area,taking our national conditions into account,to improve the accessibility of orphan drugs and alleviate the pressure of treatment of rare diseases.