FDA's 2013 NME approvals below 2012 total

FDA approved 27 NMEs in 2013, according to the agency's tally. This compares to 39 NMEs approved by the agency in 2012. According to a December presentation by John Jenkins, director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research (CDER), FDA has averaged about 26 NME approvals annually for the last 10 years. Jenkins said the agency's first cycle approval rate for NMEs has not significantly changed and attributed the lower 2013 approval tally to a decrease in the number of applications with PDUFA dates in 2013.

FDA has granted breakthrough therapy designation to 37 products since the pathway was enacted as part of the FDA Safety and Innovation Act (FDASIA) in July 2012. That includes three NMEs that the agency approved in 2013, including mostly recently HCV drug Sovaldi sofosbuvir ( GS-7977) from Gilead Sciences Inc. (NASDAQ:GILD) (see BioCentury, June 24). ...