CBER Director Touts PDUFA Progress, Therapeutic Firsts in Fiscal 2017

The Center for Biologics Evaluation and Research met or exceeded its PDUFA goals in fiscal 2017, according to CBER Director Peter Marks.

The center finished 100 percent of its fiscal 2017 cohort for standard and priority BLA and NDA reviews ahead of schedule, exceeding its PDUFA goals, he said, in an annual review. CBER further completed all 510(k) decisions within 90 days, as well as acting on 100 percent of standard and priority efficacy supplements due during the fiscal year.

The center also achieved several other milestones in FY2017, including the approval of Novartis’ CAR-T therapy Kymriah, the first gene therapy approved in the US, in August,  as well as the October approval of the second such therapy, Gilead’s Yescarta.

Other firsts in the therapeutic field included Odactra, the first under-the-tongue allergenic extract for house dust mite-induced nasal inflammation and Haegarda, the first subcutaneous preventive care treatment for hereditary angioedema.