title: Therapeutic recombinant proteins: trends in US approvals 1982 to 2002.
abstract: Recombinant proteins have become an important class of therapeutics since the first product was approved for marketing in the US in 1982. To determine trends in the clinical development and approval processes for therapeutic recombinant proteins, data for 270 products that entered clinical study in the period 1980 to 2002 were collected and analyzed. Mean clinical and approval phase lengths for 54 US-approved products stratified by time period, therapeutic indication, protein type, review rating and FDA review center are compared. Approval success rates, calculated using three methods that differ only in the definition of success, and the variation of approval success rates over five time periods are presented.
authors.affiliation: Tufts Center for the Study of Drug Development, Suite 550, 192 South Street, Boston, MA 02111, USA. janice.reichert@tufts.edu
authors.forename: Janice M
authors.initials: JM
authors.lastname: Reichert
authors.forename: Cherie
authors.initials: C
authors.lastname: Paquette
mesh_terms: D017277:Drug Approval; D004358:Drug Therapy / Q000639:trends*; D011994:Recombinant Proteins / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011994:Recombinant Proteins