News You Can Use…
Patrick Kurunwune, PharmD Candidate
Alyson Leonard, PharmD
Pete Koval, PharmD
Cone Health Family Medicine
April, 2017
FDA Approval
• Qtern® (dapagliflozin and saxagliptin)
• The first FDA approved DPP-4 inhibitor and
SGLT-2 inhibitor combination
• Formulation /Dosing
• Tablet: 10 mg dapagliflozin/5 mg saxagliptin
• FDA approved 2/28/2017 however, no
availability date at this time
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209091s000lbl.pdf
FDA Approval
• Emflaza® (deflazacourt)
• Corticosteroid indicated for the treatment of
Duchenne muscular dystrophy (DMD) in
patients 5 years of age and older
• Formulation/Dosing
• Tablets: 6mg, 18mg, 30mg, and 36mg
• Oral Suspension: 22.75 mg/mL
• Pricing
• $89,000
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf
FDA Approval
• Dupixent® (dupilumab)
• injection to treat adults with moderate-to-
severe eczema
• Class: Interleukin-4 Receptor Antagonist;
Monoclonal Antibody
• Formulation/ Dosing
• Injection: 300 mg/2 mL
• Pricing
• $37,000
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm
FDA Approval
• Ocrevus® (ocrelizumab)
• First drug approved by the FDA for primary
progressive multiple sclerosis (PPMS)
• Class: Monoclonal Antibody
• Formulation/Dosing
• Injection: 300 mg/10 mL (30 mg/mL) in a
single-dose vial
• Pricing
• $65,000 per year (2 shots per year)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf#page=17
Viberzi: FDA Drug Safety
• Viberzi® (eluxadoline)
• For the treatment of IBS
• FDA Drug Safety Alert
• Do NOT prescribe Viberzi (eluxadoline) in
patients who do not have a gallbladder
• FDA review found these patients have an
increased risk of developing serious
pancreatitis that could result in
hospitalization or death
https://www.fda.gov/Drugs/DrugSafety/ucm546154.htm
Basaglar® – Insulin Glargine
• Biosimilar Insulin Glargine AKA “Lantus®”
• Now available in the market place!
• Dose conversion – Direct 1:1
• Consider when insurance dictates
• At this time insurance coverage is in transition
• Expect plans to consider this as price appears
to be competitive
• $330 vs $ 380 (Lantus Solostar) for 5 pens
Pricing from GoodRx.com - Accessed 4/3/2017
Biosimilar Coming Soon!
• Currently about 30 “biologic specialty drugs”
pending approvals at the FDA
• 73 biologic patent expirations by 2021
• Biologic “biosimilars” serve as competing
brands
• Biosimilar Naming (FDA 1/17)
• Named by their reference biologics’ generic
names plus a four-letter suffix, such as
“filgrastim-sndz” for Sandoz’s biosimilar
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcareexecutive/news/fda-approvals-specialty-drugs-pick-2017