Drug Approvals on the Mend?

The current issue of Nature Drug Discovery contains the following interesting graph:

The author of the piece argues that the minor improvement in the absolute number of approvals in 2003 masks some important (and positive) changes at the FDA:
  1. Regulatory review of monoclonal antibodies and protein therapies in the United States was transferred to the Center for Drug Evaluation and Research (CDER) in an effort to speed things up.
  2. More importantly, 2003 marked some innovative approvals, including enfuvirtide (Fuzeon; Trimeris/Roche), bortezomib (Velcade; Millennium) and gefitinib (Iressa; AstraZeneca). Enfuvirtide, is the first HIV drug in a new class for around a decade. Bortezomib is the first proteasome inhibitor to be approved for multiple myeloma. Finally, Gefitinib is the first in a new class of targeted cancer therapies, one which inhibits the activity of the skin’s growth receptor and is being prescribed for lung cancer.
All of this is good, of course, but the cynic in me says that part of the reason the FDA has become somewhat faster at approving some biopharmaceuticals is that there are so darn few such products in the approval cycle. After all, even with the slight pick-up in submissionsin 2003, we are still sitting near decade lows.

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