Tufts CSDD: CNS Drugs Longer to Develop; Lower Success Rates
Drugs that treat central nervous system diseases take more than a year longer to develop and are less than half as likely to obtain marketing approval
Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are less than half as likely to obtain marketing approval than other drugs, according to a newly completed study by the Tufts Center for the Study of Drug Development. Mean clinical development time for CNS drugs approved for marketing in the United States from 1999 through 2013 was 12.8 months, or 18%, longer than for non-CNS compounds, according to Tufts CSDD. In addition, the overall clinical approval success rate (share of compounds entering clinical testing that obtain marketing approval) for CNS compounds first tested in human subjects from 1995 to 2007 (and followed through 2013) was 6.2%, or less than half the 13.3% rate for non-CNS drugs.
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Improving Relationships and Diversifying the Site Selection Process
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FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
