Proving Ground For “Breakthrough” Status Coming With Impending User Fee Goals
Novel drug and biologic applications with user fee goals in 2014’s second half cluster around infectious disease – notably hepatitis C, with three “breakthrough” drugs pending, antibiotics and meningitis B vaccines (also designated “breakthroughs”) – and oncology, where the first regulatory tests of the highly anticipated PD-1 immune checkpoint inhibitors are coming up.
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CDER Director Woodcock was quickly consulted about a manufacturing concern at a foreign site that emerged shortly before FDA’s target action date for Novartis’ ceritinib NDA as the agency strove to avoid delaying approval of the “breakthrough” lung cancer therapy.
Pharmacyclics exec says PDUFA V “program” meetings should be optional, as timelines for mid-cycle communication and late-cycle meeting are out of sync with highly compressed review times for some products. CDER is internally discussing whether it would be feasible to give breakthrough therapy sponsors a target date for approval.
Positive Phase III findings support Novartis’ plan for filing the pan-DAC inhibitor in 2014. The firm’s initial BLA for the compound, seeking accelerated approval in Hodgkin’s lymphoma, was rejected by FDA in 2011.