Transcript NEWS YOU CAN USE 2015 03 UPD

News You Can Use…
Pete Koval, PharmD
Alvin Oung, PharmD
Cone Health Family Medicine
March 2015
News You Can Use…
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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 2nd 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 2014
02/25/2015 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 FDAapproved 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 onceweekly 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