Second Quarter Approvals Forecast

Between now and the end of the year there are twenty-six drugs in line for FDA approval. Four of them are due prior to the end of this quarter:

• Dasotraline from Sunovion Pharmaceuticals has a PDUFA Date of May 14, 2020.The drug is an oral dopamine and norepinephrine reuptake inhibitor that is being reviewed for the treatment of moderate-to-severe binge eating disorder
• Inebilizumab has a PDUFA Date of June 11, 2020. Viela Bio and AstraZeneca are collaborating on this intravenous Monoclonal Antibody for the treatment of Neuromyelitis optica spectrum disorder (NMOSD). When approved inebilizumab will compete with eculizumab (Soliris, Alexion). Another investigational drug for NMSOD, satralizumab, from Roche, Chugai has a PDUFA date of 8/29/2020.
• Nabriva Therapeutics and Zavante Therapeutics are working together to develop an intravenous formulation of fosfomycin The drug has a PDUFA Date of June 19, 2020 and is being reviewed for the treatment of complicated urinary tract infections.
• The combination of bupivacaine and meloxicam from Heron Therapeutics has PDUFA Date of Jun 26, 2020. The extended-release local anesthetic and NSAID combination is delivered through a surgical site Implant to reduce the need for opioids during the first 72 hours after surgery.