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“Extracting Knowledge from Failed Development Programmes”

NDA/BLA transition success rates (approval rates) for the disease areas listed in Figure 2b ranged from the low end of 77.5% (Ophthalmology) to a high of 94.6% (Respiratory). The distribution of rates (17.1%) were within the tightest range among the four phases analyzed in this report. These rates are the result of eventual success, not success on first review, meaning some programs may have as many as four Complete Response Letters (CRLs) and attempts at approval. This unrestricted time-frame and number of re-submissions pushes the overall success above 85% across all diseases. When looking at how many original NDA/BLA filings were approved on the first review by FDA, the rates are far from concentrated (Figure 5). In fact, Psychiatry had only a 37% chance of first-cycle approval vs. Oncology at nearly 80%. Although this is an extreme range, upon subsequent submissions and reviews, both of these disease areas ended up with 91% of original drug indication applications being approved. There was a large increase in cumulative success rates after the second submission, but only marginal increases after the third review. Time from filing to approval also varied by disease area. Neurology drugs took the longest to approve on average, at 2 years, while Oncology drugs were approved almost twice as fast at 1.1 years. Many Oncology drugs for unmet medical need may have benefited from expedited approval pathways and associated increased interactions with FDA such as Breakthrough Therapy and Accelerated Approval, contributing to the faster overall time to approval. As might be expected, calculating time to approval for all disease areas put the time to approval in the middle of these extremes, at 1.6 years.