Posted by: tristar3research | February 3, 2009

US FDA approvals in 2008 totaled 21 new molecular entities (NMEs)

Specialty products continued to dominate new drug and biologic approvals in the US in a year in which the evolving regulatory environment also featured heavily. US FDA approvals in 2008 totaled 21 new molecular entities (NMEs) and 3 biologic license applications (BLAs) that were evaluated by the Center for Drug Evaluation and Research (CDER) Tables 1, 2). For some, this slight increase in approvals compared with recent years (Fig. 1) is cause for optimism. “It still falls far short of the approval rate seen in the 1990s, and we do need to see more consistency in terms of that number increasing each year, but overall it is encouraging,” says Andrew Jones, Senior Pharmaceutical Analyst, Ernst & Young, London, UK. However, there are some situations in which the regulatory process is considered likely to be smoother. “The theme is the same: if you are going for a rare disorder or a very severe disease, such as with Treanda [bendamustine hydrochloride, developed by Cephalon for chronic lymphocytic leukemia], you have a better shot at getting the FDA to turn around your application without any delay,” says Schmidt. In this case, the new drug application (NDA) for bendamustine hydrochloride, an orphan drug, was submitted in September 2007, received priority status in December 2007 and received approval in March 2008. This perception of approvals being more straightforward for such products may help explain why the majority of NME and BLA approvals this year were for specialist-care indications, suggests Philip Ma, Director in the Silicon Valley office of McKinsey & Company. (However), the reasons that the FDA has given for not meeting PDUFA goals include increased workload, in part related to the FDA Amendments Act (FDAAA) 2007, which introduced new authorities to require post-market studies, safety labelling changes, and risk evaluation and mitigation strategies (REMS). Source: Nature


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