The FDA approved 17 new molecular entities (NMEs) and two biological license applications in 2007, the lowest number of new approvals since 2002. Nine of the 19 approvals were the subject of priority review status, which is given to a drug for which few available treatments exist. Four of the new approvals were for oncology drugs. However, two drugs (Sanofi-Aventis’ Acomplia and Novartis’s Galvus) that were expected to win approval did not, despite being approved in the EU. The FDA’s increasing safety concerns, new draft guidelines for antibacterial development and a growing workload are cited by experts as reasons for the low approval rate. In addition, the number of approvable letters, which state what conditions must be met for a drug to be approved increased. Approvable letters accounted for 28% of FDA decisions in 2007, up from 20% in 2006, with biotech drugs representing 75% of three-month delays. Of the new drugs approved last year, Gilead’s Letairis for pulmonary arterial hypertension and Merck’s for HIV-1 are expected to be the most successful. Source: Nature Reviews Drug Discovery

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