While the number of new molecular entities (NME) filed in 2013 (a subset of all NDAs filed) was lower than in 2012 (36 vs 41), there are some interesting facts associated with how CDER did on approvals. For instance, of the 36 NMEs filed in 2013, FDA approved 27. This compares with 39 of the 41 submitted in 2012. The number of applications filed may include those that were still undergoing their 60 day filing review. FDA received about 136 NDA/BLA in CDER. This clearly does not represent the CDER workload under PDUFA as it excludes NDA resubmissions, supplements (both efficacy and CMC), not to mention all of the other PDUFA commitments that the Center has to meet. But nonetheless, here are some of the interesting statistics that FDA reports for its work on NME applications which are defined by FDA as “a drug for which the active ingredient has never before been approved or marketed in the United States in any form.”
Of the 27 NME applications approved, 9 were first-in-class and 9 were for orphan drug products. FDA also reported on the number of applications approved through their innovative approval methods; 10 were approved under the fast track program, 3 through the new breakthrough drug program, 10 received priority review and 2 were approved under the accelerated approval process.
Most astonishingly, 24 of the 27 NMEs approved in 2013 were approved in the first review cycle which represents an 88% first cycle approval rate! This shows how the interaction between the Agency and industry can work through the review process. Wouldn’t it be nice if generic drugs had even a 10% first cycle approval rate?
20 of the 27 applications (or 74%) approved for NMEs had their first approval in the United States. Another striking statistic!
The successful effort of FDA in approving NME applications and in a timely manner is commendable. The scope of review for a product that has never been approved in the US (or for that matter, in the world) presents some unique challenges relative to both safety and efficacy issues. The escalation of PDUFA fees in accordance with industry negotiations for additional programs for both NME and non-NME NDAs shows that the program is working well. Kudos for the New Drug Review teams and the Center for their accomplishments and kudos also to industry for providing the Agency quality applications and working well with FDA to meet the objectives of both, that is, to get safe and effective products to market. To see a list of the NMEs approved in 2013, click here.
