2016 Novel Drug Summary
22 NOVEL DRUGS
Innovative products that serve unmet medical needs/significantly advance patient care. Have chemical structures that have never been approved before.
Adlyxin, Anthim, Axumin, Briviact, Cinqair, Defitelio, Epclusa, Eucrisa, Exondys 51, Lartruvo, Netspot, Nuplazid, Ocaliva, Rubraca, Spinraza, Taltz, Tecentriq, Venclexta, Xiidra, Zepatier, Zinbryta, Zinplava
SUMMARY
- Impact: Public health, First-in-class, Rare diseases
- Innovation: Breakthrough, Fast Track, Pirority Review, Accelerated Approva
- Predictability: Met PDUFA goal date
- Access: First cycle approval, First approval in US