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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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