News You Can Use… Pete Koval, PharmD Alvin Oung, PharmD Cone Health Family Medicine March 2015

News You Can Use… This news cycles automatically & IS INTENDED to provide incentive to arriving early! Thanks for coming early!

New Drug Approval Avycaz (ceftazidime + avibactam) received FDA approval for the treatment of complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis This is the 2 nd cephalosporin/β-lactamase inhibitor combination approved for use in patients who have limited or no alternative treatments in cIAIs and/or cUTIs Zerbaxa (ceftolazane + tazobactam) was approved in December /25/2015 FDA News and Events

New Drug Approval Savaysa (edoxaban) received FDA approval for the treatment of DVT/PE and prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation Similar MOA to rivaroxaban and apixaban Shown to have similar efficacy and reduced bleeding risk compared to warfarin but with various restrictions, ex: contraindicated in CrCl > 95 ml/min 01/08/2015 CenterWatch

New Drug Approval Toujeo (insulin glargine [rDNA origin] injection, 300 U/ml]), a once-daily long-acting basal insulin, received FDA approval to treat Type 1 and Type 2 diabetes Same active ingredient as Lantus, but at three times the concentration and suggested to have a design to release insulin more gradually Lower rates of hypoglycemia were seen in clinical trials by not mentioned in the FDA- approved label 02/25/2015 FDA News and Events

In the pipeline Novo Nordisk announced that it has successfully completed its Phase 2 trial for once-daily oral semaglutide vs once- weekly subcutaneously administered semaglutide (in Phase 3) This would be the first oral GLP-1 receptor agonist for the treatment of Type 2 diabetes 02/20/2015 ClinicalTrials.gov

New Drug Approval Farydak (panobinostat) received FDA approval for the treatment of patients with multiple myeloma This is the first HDAC (histone deacetylase) inhibitor approved to treat multiple myeloma Intended to be used in combination with bortezomib and dexamethasone 02/23/2015 FDA News and Events

New Drug Approval Lucentis (ranbizumab) 0.3 mg injection received expanded approval from the FDA to treat diabetic retinopathy in patients with diabetic macular edema The FDA previously had approved Lucentis to treat DME and macular edema secondary to retinal vein occlusions Lucentis is also approved to treat wet age- related macular degeneration 02/06/2015 FDA News and Events

Hepatitis C Medication Updates Daclatasvir, with sofosbuvir, shows 97% SVR12 rates in genotypes 1-4 with co-infected HIV patients in Phase 2 Trials Gilead announces 96% SVR12 Rates from Phase 3 Study evaluating Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for Hepatitis C genotypes 1 or 4 among patients co-infected with HIV on ART Plans to file supplemental New Drug Application 02/26/2015 Hepatitis C New Drug Research

New Drug Approval Cosentyx (secukinumab) received approval from the FDA for the treatment of moderate to severe plaque psoriasis This is the first approved human monoclonal antibody that selectively inhibits IL-17A 01/21/2015 FDA News and Events