Cone Health Family Medicine News You Can Use… Jennifer Otter, PharmD Pete Koval, PharmD Cone Health Family Medicine September 2017

New Drug Approval Mavyret® (glecaprevir/pibrentasvir) for Hepatitis C Virus (HCV) Indicated for adult patients with chronic HCV genotypes 1-6 w/out cirrhosis or w/ mild cirrhosis First 8-week treatment approved for all HCV genotypes Also approved for HCV patients “who have previously been treated w/ NS5A inhibitor or an NS3/4A protease inhibitor but not both”. Standard treatment = 12 weeks 8/3/2017 FDA.gov

New Drug Approval Gocovri® (amantadine ER) Indicated for treatment of dyskinesia in patients with Parkinson’s receiving levodopa-based therapy Price TBD. List price estimated 10-30K Generic amantadine currently used off- label for dyskinesia. ~$2 per 100 mg capsule 8/24/2017 FDA.gov

New Indication Austedo® (deutrabenazine) is another VMAT 2 inhibitor that regulates dopamine levels Previous indication: chorea associated with Huntington Disease New indication: tardive dyskinesia (second in class) Ingrezza® (valbenazine) was the first VMAT 2 inhibitor indicated for TD Approval date: 4/11/17 8/30/2017 FDA.gov

New ALS Drug (now available) Radicava® (edaravone) is a free radical scavenger that reduces oxidative stress Indicated for treatment of ALS. Study showed slowed decline in physical functions by 33% in ALS pts First ALS drug in 20 years Administration: 1 hr daily infusion (60 mg dose) x 2 weeks, followed by 2 week drug- free period, then daily infusions x 10 days. $1,000 per dose ($146,000/year – cash) Now available 8/14/2017 MTPA Press Release

New Drug Approval Duzallo® (lesinurad/allopurinol) approved for gout New combination formulation for gout treatment targeting both overproduction and underexcretion of uric acid Expected to be commercially available by late 2017 Lesinurad (Zurampic) previously approved separately as add-on therapy to allopurinol or febuxostat 8/21/2017 FDA.gov

New Drug Approval Vabomere® (meropenem/vaborbactam) approved for complicated* UTIs 98% cure rate vs 94% with Zosyn Recommended dose: 4 g IV infusion for 3 hours q 8hrs Max treatment duration is 14 days Price TBD *Includes pyelonephritis Meropenem 2 g – vaborbactam 2 g 3 hour infusion q 8 vs piperacillin 4 g –tazobactam 500 mg 30 min infusion q 8 X 10 days 8/30/2017 FDA.gov

New Drug Approval Kymriah® (tisagenlecleucel) approved for acute lymphoblastic leukemia (ALL) First CAR-T therapy for lymphoblastic leukemia in those whose cancer is refractory or has relapsed ≥ 2x Overall remission rate within 3 months of treatment: 83% Cash price: $475,000 (one time treatment) Chimeric antigen receptor T cell T cells target and kill leukemia cells that have a specific antigen (CD19) on the surface 8/31/2017 FDA.gov

FDA - Priority Review Emicizumab is a recombinant humanized antibody Indicated for Hemophilia A Binds to factors IXa and X, substituting for the role of factor VIIIa. Subcutaneously administered, once weekly FDA expected to make a decision on approval by February 23rd 2018. 8/25/2017 FDA.gov

New Indication Approval Victoza® (liraglutide) is a GLP-1 agonist Indicated to improve glycemic control and weight loss in DM2 New indication: reduces risk of heart attack, stroke and CV death Joins Jardiance (empagliflozin) as DM agents with demonstrated official CV benefits 8/28/2017 FDA.gov

Drug to be Removed From Market GSK released a statement to discontinue Tanzeum (albiglutide), a GLP-1 agonist, by July 2018 due to declining sales. 7/26/17 GSK Press Release

New Study Oral GLP-1 (semaglutide) tops Trulicity (dulaglutide) in Phase 3 trial Statistically significant difference in reducing glucose levels and lowering body weight in Type 2 diabetes. Semaglutide 0.5 mg vs Trulicity 0.75 mg 1.5% vs 1.1% A1c lowering (baseline A1c 8.2) 4.6 kg vs 2.3 kg weight loss Semaglutide 1 mg vs Trulicity 1.5 mg 1.8% vs 1.4% A1c lowering (baseline A1c 8.2) 6.5 kg vs 3.0 kg weight loss Mean baseline A1c: 8.2% 8/16/2017 Reuters.com