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:
- 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.
- 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.