Average Approval Time Slows As FDA Clears Greater Number Of NMEs In 2004
This article was originally published in The Pink Sheet Daily
Executive Summary
Average time to approval was 18.7 months for a new molecular entity in 2004, versus 17.1 in 2003. FDA cleared 31 NMEs in 2004, 10 more than the prior year. CDER appears to be setting a strong precedent with its first year of therapeutic biologic reviews.
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The average time to approval for a new molecular entity rose to 18.7 months in 2004, versus 17.1 months in 2003. The longer time to approval (measured from date of first submission) accompanies an increase in the number of NME approvals in 2004. The final tally of 2004 NME approvals was 31, compared to 21 in 2003 (1 (Also see "FDA Clears 31 New Molecular Entities In 2004, Up Ten From Previous Year" - Pink Sheet, 3 Jan, 2005.)). For its official count, FDA intends to add the number of new therapeutic biologics to the number of NMEs, which brings the total for all novel therapeutics to 36. Review of therapeutic biologics was transferred to the Center for Drug Evaluation & Research under a reorganization completed in October 2003. The combined average approval time for NMEs and therapeutic biologics in 2004 was 19.3 months. For therapeutic biologics approved in 2003, the average was 20.9 months; 2003's average approval time for all biologic approvals was 36.9 months. The combined therapeutic biologic and NME average approval time in 2003 was 19 months; the total number of approvals was 28. With 56 months from submission to approval, Palatin's imaging agent NeutroSpec had the longest review period of 2004's therapeutic biologics. Without NeutroSpec, the mean time to approval for therapeutic biologics in 2004 falls to 11.2 months. Without the longest review in 2003 (241.6 months for Aventis' tetanus and diphtheria vaccine), the average was 21.2 months. Excluding outliers, CDER seems to have brought about a significant improvement in biologic review times during the first year of its purview over therapeutic biologics. In addition to NeutroSpec, CDER approved Genentech's Avastin , Bristol-Myers Squibb/ImClone's Erbitux , Amgen's Kepivance and Biogen Idec's Tysabri in 2004. Indeed, excluding Erbitux - which received a "refuse to file" letter and awaited completion of additional clinical trials - CDER's incipient Office of Drug Evaluation VI managed to beat the review clock, with an average approval time of 5.7 months. Avastin was the quickest, with approval in 5.1 months, while Kepivance and Tysabri were both approved at the six-month priority review deadline. All three were submitted after CDER had taken over therapeutic biologic reviews. The lowest times to approval were the dual bioterror products for radiation contamination - Pharma Hameln GmbH's pentetate calcium and pentetate zinc were each cleared in 3.5 months. The fastest turnaround for a therapeutic drug was Genentech/OSI's non-small cell lung cancer therapy Tarceva at 3.7 months. FDA cleared out several applications that had been pending at the agency for a number of years. There were four NMEs approved on their third review cycle (Lilly's Cymbalta , Aventis' Ketek , Pfizer's Lyrica and Bracco's MultiHance ). Twelve were approved more than two years after the first submission. FDA's lengthiest review for an NME approved in 2004 was Elan's chronic pain agent Prialt , which was approved 60 months after its first submission. Adjusting the approval times for these long-lingering products brings the NME average time to approval down to 9.2 months. [Editor's Note: Further analysis of FDA's 2004 performance appears in the January issue of Pharmaceutical Approvals Monthly. For a sample copy, call customer service at 800-332-2181.] - Mary Jo Laffler |