New Drugs of 2016: Part 1PharMEDium Lunch and Learn Series
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New Drugs of 2016: Part 1
April 7, 2017
Featured Speaker: Mary Lynn Moody, BSPharmDirector, Business DevelopmentDrug Information and Prior Authorization GroupUniversity of Illinois at Chicago
LUNCH AND LEARN
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Mary Lynn Moody BSPharm
Clinical Associate Professor
Department of Pharmacy Practice
University of Illinois at Chicago
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New Drugs of 2016: Part 1PharMEDium Lunch and Learn Series
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Learning Objectives-Pharmacists
Describe the new drugs approved by the Food and Drug Administration in 2016
Discuss the role of these agents in therapy
Summarize the adverse effects and potential drug interactions of these new agents
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Learning Objectives- Technicians
Describe the new drugs approved by the Food and Drug Administration in 2016
Discuss any unique preparation and/or dispensing requirements for these agents
Summarize the adverse effects and potential drug interactions of these new agents that may require pharmacist intervention
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New molecular entities (NME)
Refer to handout for the next three slides
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2016 –Not a Blockbuster Year 1
22 new molecular entities (NME)
Much lower than last year (45)
Below average of 29/year
5 approved in 2015 ahead of schedule
75% qualified for at least 1 expedited designation
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Breakthrough Status2
This designation authorized by Congress in 2012
Reserved for agents that treat serious or life threatening diseases or conditions or provide substantial improvement over existing therapy
FDA will expedite the development and review of these agents
This year, 32% (7/22) drugs were awarded that breakthrough status
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Orphan drugs2
41% (9/22) approved for orphan diseases
Orphan diseases occur in < 200,000 patients in US
25 million total patients in this category
Financial incentives, tax credits, fee waivers
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Lixisenatide (Adlyxin)3
Approved July 27, 2016
5th glucagon-like peptide-1 (GLP-1) receptor agonist
Approved to treat type 2 diabetes mellitus
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Lixisenatide Pharmacokinetics4
Administer within one hour prior to the first meal of the day
Administer subcutaneously in the abdomen, arm or thigh
No difference in rate of absorption
Excreted through glomerular filtration
Elimination half life: 3 hours
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Lixisenatide dosing4,5
Available as 50 mcg/mL, 100 mcg/mL prefilled syringes
Dose is 10 mcg once a day subcutaneously for 14 days
Increase to 20 mcg if needed
Administer within 1 hour prior to the first meal of the day
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Lixisenatide Efficacy6
Head to head comparison to exenatide
Non-inferior to twice daily exenatide
50% of patients in each group achieved HbA1c < 7%
Both drugs exhibited some weight loss
Lixisenatide had less hypoglycemia and GI effects
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Lixisenatide ELIXA trial7
6,068 diabetic patients with MI or unstable angina (6 mos)
Median follow up was 25 months
Designed to assess risk for MI, stroke, hospitalization
Not associated with difference in cardiovascular outcome compared to placebo
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Lixisenatide4,5
Contraindications/Warnings Hypersensitivity/antibody development Pancreatitis risk Renal damage
Adverse effects Hypoglycemia in combination with insulin or
sulfonylureas Nausea (25%) Vomiting (10%) Headache (9%) Diarrhea (8%) Dizziness (7%)
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Lixisenatide Place in therapy
Crowded market
Victoza®-market leader for years
No cardiovascular benefit like Victoza®
Some benefit in patients with GI or hypoglycemia with other GLP-1 agents
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Pharmacist Clinical Points
Be sure patient can demonstrate proper use
Need a new needle each day
Explain what to do if dose is missed, give within hour of next meal
Be sure to educate patient about hypoglycemia and how to manage
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Technician Points
Check to see if the patient needs to have the pharmacist review pen activation process
Be sure patient has needles and supplies when they pick up medication
Notify the pharmacist if the patient does not fill prescription regularly
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Hepatitis C8
Paradigm shift since 2011
Direct acting antiviral (DAA) agents Changed approach to care
Increased effectiveness
In 2014, combination products are an option for an all-oral therapy approach with exceptional efficacy rates (>90%)
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Hepatitis C9
www.Hcvguidelines.org
Response is measured by sustained virologic response (SVR) No detectable HCV RNA ≥ 12 weeks after tx
New combinations have SVR rates near 100%
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Elbasvir and grazoprevir (Zepatier)10
Approved January 28, 2016
Combines 2 DAAs
Approved for the treatment of chronic HCV genotype 1 or 4 infection in adults.
70% of HCV cases are genotype 1 in the US
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Elbasvir and grazoprevir11
Two different mechanisms of action Work at different steps in the virus lifecycle Extensively bound to plasma proteins
(>98.8%) T ½ of elbasvir is 24 hours and 31 hours
for grazoprevir Partially eliminated by oxidative
metabolism, primarily by CYP3A Primary route of elimination: feces (90%)
with less than 1% excreted in urine
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Patients should be tested for hepatitis B infection (HBV) and NS5A resistance if genotype 1a
The recommended dose-one tablet once a day for 12 weeks
No dosage adjustment for renal impairment
Elbasvir and grazoprevirdosing 5, 11
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Dosing duration 11
Patient Type Recommended treatment duration
Genotype 1a or 1b:Treatment naïve or previous treatment with peginterferon and ribavirin
12 weeks
Genotype 4:Treatment naïve 12 weeks
Gentotype 1a and high level NS5A polymorphism
16 weeks in combination with ribavirin
Genotype 1a or 1b previously treated with peginterferon, ribavirin and protease inhibitor
12 weeks in combination with ribavirin
Genotype 4 previously treated with peginterferon and ribavirin
16 weeks in combination with ribavirin
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Elbasvir and grazoprevir- Efficacy12-14
5 clinical trials that included both treatment –naïve as well as treatment –experienced patients
C-EDGE - 306 patients with genotype 1 or 4 were treated for 12 weeks
SVR12 rates were 95% for the genotype1 patients and 100% for the genotype 4 patients
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Elbasvir and grazoprevir –Efficacy14
Stage 4 and 5 kidney disease (C-SURFER)
122 patients enrolled in the trial
SVR12 rate was 94%
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Elbasvir and grazoprevir11
Contraindications Moderate to severe liver disease
Black Box HBV reactivation risk
Screen all patients for HBsAg and anti-HBcbefore starting treatment
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Elbasvir and grazoprevir 11
Warnings Elevated liver enzyme called alanine
aminotransferase (ALT) ○ 1% of patients
○ Women, Asians, elderly
Avoid in severe liver damage
No information in pregnancy or lactation
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Elbasvir and grazoprevir 5,11
Drug Interactions- Contraindicated Anticonvulsants
Rifampin
St John’s Wort
Efavirenz
HIV medications
Cyclosporine
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Elbasvir and grazoprevir11
Drug interactions- Warnings Nafcillin, ketoconazole
Rosuvastatin, atorvastatin
Etravine
Tacrolimus
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Elbasvir and grazoprevir 5,11
Adverse effects Common: nausea, fatigue and headache
Rare: Increased ALT levels (1%)
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Pharmacist Clinical Points
Initial detailed counseling session
Importance of adherence and the risks of developing resistance
Probe for any potential barriers to adherence and address them
HBV reactivation: Verify screening was done; Discuss risks of reactivation
Review significant drug interactions
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Technician Tips
Make a reminder in the computer to alert pharmacist if the patient does not return for refill
Alert pharmacist if the patient is purchasing an OTC product to prevent interactions
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Epclusa 15
Approved June 28, 2016
1st fixed dose combination for all HCV genotypes
First single tablet regimen for genotype 2 and 3 that does not require ribavirin
Potential to eliminate need for genotype testing
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Epclusa Pharmacology 5,16
Sofosbuvir inhibits the HCV NS5B RNA-dependent RNA polymerase
Velpatasvir inhibits HCV NS5A protein which is necessary for viral replication
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Epclusa 16
Approved for the treatment of HCV genotypes 1,2,3,4,5,and 6 infections
Decompensated cirrhosis: Epclusa and ribavirin
All patients should be tested for current or prior HBV infection before starting Epclusa
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Epclusa dosing 5,16
One tablet once a day for 12 weeks
Can be taken with or without food
In decompensated cirrhosis, combine Epclusa with ribavirin for 12 weeks
No dose recommendation for severe renal impairment
Can use standard dose in patients with hepatic impairment
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Epclusa Efficacy 17-19
Trial Genotype Results
ASTRAL-1 1,2,3,4,5,6 99% vs. placebo
ASTRAL-2 2 99% vs 94% (sofosbuvir and ribavirin)
ASTRAL-3 3 95% vs 80% (sofosbuvir and ribavirin)
ASTRAL-4 (decompensated)
1,2,3,4,5,6 83-94%
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Epclusa Warnings 16
HBV reactivation
Serious bradycardia
Caution when used with ribavirin
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Epclusa adverse effects 16
Common adverse effects: headache, fatigue, nausea, asthenia and insomnia
Less common: rash (2-5%) and depression (1%)
Serious symptomatic bradycardia when combined with amiodarone
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Epclusa drug interactions 16
Serious symptomatic bradycardia when combined with amiodarone
Reduced effects of Epclusa Acid blocking/neutralizing drugs
Anticonvulsants
Rifampin
Some HIV drugs, St John’s Wort
Increased digoxin levels when combined
Increase levels of statins when combined
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Pharmacist Clinical Points
Initial detailed counseling session
Importance of adherence and the risks of developing resistance
Probe for any potential barriers to adherence and address them
HBV reactivation: Verify screening was done; Discuss risks of reactivation
Review significant drug interactions
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Technician Tips
Make a reminder in the computer to alert pharmacist if the patient does not return for refill
Alert pharmacist if the patient is purchasing an OTC product to prevent interactions
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Eteplirsen 20
Approved September 19, 2016
Accelerated approval pathway as an orphan drug
Seventh rare pediatric disease priority review voucher issued
Confirmed mutation of the dystrophin gene amenable to exon 51 skipping Which affects about 13% of the population
with Duchenne Muscular Dystrophy (DMD)
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Eteplirsen 21
Antisense oligonucleotide Binds to exon 51 in the RNA that codes for
dystrophin Allows “skipping” of exon 51
Formation of a partially functional dystrophin protein
The plasma protein binding of eteplirsen is low (6-17%)
Volume of distribution of the drug is 600 mL/kg
Primarily excreted through the kidneys and the elimination half-life is 3 to 4 hours
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Eteplirsen Dosing 5,21
30 mg/kg of body weight once a week
Infused over 35 to 60 minutes
Dilute in 0.9% sodium chloride to a final volume of 100 to 150 mL
Not studied in patients with liver or kidney disease so dose adjustments are not reported
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Eteplirsen Efficacy 22
FDA Advisory Committee did not support approval Not enough evidence FDA Commissioner interceded and approved the
agent in spite of this Pivotal clinical trial included only 12 boys with DMD Surrogate end-point of dystrophin increase in
skeletal muscle not clinical improvement Substantial flaws in the initial clinical trial submitted FDA required the manufacturer to conduct additional
studies to keep approval
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Eteplirsen Side Effects 21
Common side effects: Balance (38%)
Vomiting (38%)
Skin rash (25%)
Other adverse effects (≥10%) confusion, arthralgia, severe itching, catheter
site pain, and upper respiratory tract infection
Rare: transient erythema, facial flushing, and elevated temperature on the days that eteplirsen was administered
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Pharmacist Clinical Points
Limited to Specialty Pharmacies
Counsel the parents/guardian of the child
Administered intravenously once a week Specialty pharmacy or home compounded?
Pharmacists may recommend an anesthetic cream for the infusion
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Technician Tips
Allow vials to warm to room temperature
Do not shake
Administer immediately, no preservative
Dilute in 0.9% sodium chloride only
Final volume of 100 to 150 mL
Can store final product in refrigerator for 24 hours if needed
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Bezlotoxumab(Zinplava) 23
October 21, 2016
Fast Track Approval
Reduce the recurrence of Clostridium difficile infection (CDI)
Use with an antibacterial drug
NOT approved to treat CDI
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Bezlotoxumab 24
Human monoclonal antibody
Binds to C. difficile toxin B and neutralizes effect
Eliminated by catabolism so no need to adjust dose in renal or liver impairment
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Bezlotoxumab Dosing 24
Single dose: 10 mg/kg administered as an intravenous infusion
Dilute drug with 0.9% sodium chloride or Dextrose 5% in water
Final concentration ranges from 1 mg/mL to 10 mg/mL
Use a 0.2 to 5 micron in-line filter Administer over 60 minutes. Do not
administer IV push or bolus
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Bezlotoxumab Efficacy 24
MODIFY I and II studies enrolled 2,655 patients
Both hospital and outpatient settings
Primary endpoint –recurrence of CDI within 12 weeks: lower with Zinplava(17.4%, p=0.0003) compared to 27.6% in placebo
Higher risk of heart failure in at risk patients
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Bezlotoxumab Warnings 24
No contraindications
Heart failure reported in trials History of heart failure: 12.7% in Zinplava
group; 4.8% in placebo group
Reserve use when benefit outweighs risk in patients with history of heart failure
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Bezlotoxumab Adverse Effects 24
Common Infusion related reactions (10%)
Nausea (7%)
Pyrexia (5%)
Headache (4%)
Rare Ventricular tachyarrhythmia
Heart failure
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Pharmacist Clinical Points
Confirm patient is receiving antibacterial for CDI
Do not co-administer in the same line with other drugs
May administer via central or peripheral line
Only single dose therapy
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Technician Tips
Must dilute prior to administration
Do not shake vial
Dilute with 0.9% sodium chloride or Detrose 5% in Water to final concentration of 1 mg/mL to 10 mg/mL
May store 16 hours at room temp or 24 hours refrigerated
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Conclusions
Much fewer number of drugs approved in 2016
Majority of those approved were orphan, fast track agents
Not much impact on compounding business
Critical to understand these new agents
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References1. United States Food and Drug Administration. Novel Drug Approvals 2016.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm. Accessed January 8, 2017.2. United States Food and Drug Administration. Novel Drugs Summary 2016.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863.htm. Accessed March 3, 2017.3. United States Food and Drug Administration. FDA approves Adlyxin to treat type 2 diabetes.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm513602.htm. Accessed March 3, 2017.4. Adlyxin [package insert]. Bridgewater NJ: Sanofi-Aventis LLC. July 2016.5. Facts and Comparisons. [database online] Indianapolis, IN: Clinical Drug Information. LLC;
http://online.factsandcomparisons.com. Accessed January 15, 2017.6. Rosenstock J, Raccah D, Koranyi L et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in
type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2013;36(10):2945-2951. 7. Pfeffer MA, Claggett B, Diaz R et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N
Engl J Med. 2015;373(23):2247-2257.8. McCaughan GW. New therapies against HCV: Expected risks and challenges associated with their use in the liver
transplant setting. J Hepatol. 2012;57(6):1361-1667.9. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org.
Accessed March 1, 2017.10. United States Food and Drug Administration. FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1
and 4. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm. Accessed March 4, 2017. 11. Zepatier [package insert]. Whitehouse Station NJ: Merck & Co., Inc. February 2017.12. Rockstroh JK, Nelson M, Katlama C et al. Efficacy and safety of gazoprevir (MK-5172) and elbasvir (MK-8742) in
patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015;2(8):e319-e327.
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References13. Buti M, Gordon SC, Zuckerman E et al. Grazoprevir, elbasvir, and ribavirin for chronic hepatitis C virus
genotype 1 infection after failure of pegylated interferon and ribavirin with an earlier-generation protease inhibitor: Final 24-Week results from C-SALVAGE. Clin Infect Dis. 2016;62(1):32-36.
14. Roth D, Nelson DR, Bruchfeld A et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386(10003):1537-1545.
15. United States Food and Drug Administration. FDA approves Epclusa for treatment of chronic Hepatitis C virus infection. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm. Accessed March 5, 2017.
16. Epclusa [package insert]. Foster City CA: Gilead Sciences, Inc. February 2017.
17. Younossi ZM, Stepanova M, Feld J. et al. Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: results from ASTRAL-1 placebo-controlled trial. J Hepatol. 2016;65(1):33–39.
18. Younossi ZM, Stepanova M, Sulkowski M et al. Ribavirin-free regimen with sofosbuvir and velpatasvir is associated with high efficacy and improvement of patient-reported outcomes in patients with genotypes 2 and 3 chronic hepatitis C: Results from Astral-2 and -3 clinical trials. Clin Infect Dis.2016;63(8):1042-1048.
19. Younoss ZM, Stepanova M, Charlton M et al. Patient-reported outcomes with sofosbuvir and velpatasvir with or without ribavirin for hepatitis C virus-related decompensated cirrhosis: an exploratory analysis from the randomised, open-label ASTRAL-4 phase 3 trial. Lancet Gastroenterol Hepatol. 2016;1(100031):122–132.
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References20. United States Food and Drug Administration. FDA grants accelerated approval to first drug for Duchenne
muscular dystrophy. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm521263.htm. Accessed March 6, 2017.
21. Exondys 51 [package insert]. Cambridge MA: Sarepta Therapeutics Inc. September 2016.
22. Eteplirsen (Exondys 51) for duchenne muscular dystrophy. Med Lett Drugs Ther. 2016 Nov 7;58(1507):145-146.
23. United States Food and Drug Administration. FDA approves Merck’s ZINPLAVA™ (bezlotoxumab) to reduce recurrence of Clostridium difficile infection (CDI) in adult patients receiving antibacterial drug treatment for CDI who are at high risk of CDI recurrence. http://www.mercknewsroom.com/news-release/corporate-news/fda-approves-mercks-zinplava-bezlotoxumab-reduce-recurrence-clostridium-. Accessed March 29, 2017.
24. Zinplava [package insert]. Whitehouse Station NJ: Merck and Company. October 2016.
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New Drugs of 2016 Table 1- New drugs of 2016, listed in order of approval date1
Generic Name Brand Name Approval Date Indication Elbasvir (ELB as vir) and Grazoprevir (graz OH pre vir)
Zepatier (ZEP-ah-teer)
1-28-2016 Chronic hepatitis C (HCV) genotypes 1 and 4 infection
Brivaracetam (BRIV a RA se tam)
Briviact 2-18-2016 Partial onset seizures
Obiltoxaximab (oh-bil-tox-AX-i-mab)
Anthim 3-18-2016 Inhalational anthrax
Ixekizumab (IX ee KIZ ue mab)
Taltz 3-22-2016 Moderate to severe plaque psoriasis
Reslizumab (res LIZ ue mab)
Cinqair 3-23-2016 Severe asthma
Defibrotide sodium (de FYE broe tide)
Defitelio 3-30-2016 Hepatic veno-occlusive disease following stem cell transplant
Venetoclax (ven ET oh klax)
Venclexta 4-11-2016 Chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
Pimavanserin (PIM a VAN ser in)
Nuplazid 4-29-2016 Treatment of hallucinations and delusions from psychosis in Parkinson’s disease
Atezolizumab (A te zoe LIZ ue mab)
Tecentriq 5-18-2016 Urothelial type bladder cancer
Daclizumab (dah KLIH zyoo mab)
Zinbryta 5-27-2016 Multiple sclerosis
Obeticholic acid (oh BET i KOE lik AS id)
Ocaliva 5-27-2016 Rare chronic liver disease
Fluciclovine F 18 Axumin 5-27-2016 Diagnostic imaging agent for recurrent prostate cancer detection
Gallium Ga 68 dotatate (GAL-ee-um Ga 68 DOE-ta-tate)
NETSPOT 6-1-2016 Diagnostic imaging agent for rare neuroendocrine tumors
Sofosbuvir (soe FOS bue vir) and Velpatasvir (vel PAT as vir)
Epclusa 6-28-2016 Treatment of all 6 major forms of hepatitis C virus
Lifitegrast (LIF e TEG rast)
Xiidra 7-11-2016 Treat signs and symptoms of dry eye
Lixisenatide (LIX i SEN a tide)
Adlyxin 7-27-2016 Diabetes type 2
Eteplirsen (e TEP lir sen)
Exondys 51 9-19-2016 Duchenne muscular dystrophy
Olaratumab (OH lar AT ue mab)
Lartruvo 10-19-2016 Soft tissue sarcoma
Bezlotoxumab (BEZ loe TOX ue mab)
Zinplava 10-21-2016 Reduce the recurrence of Clostridium difficile infection in adults
Crisaborole (KRIS a BOR ole)
Eucrisa 12-14-2016 Atopic dermatitis in patients two years of age or older
Rucaparib (roo KAP a rib)
Rubraca 12-19-2016 Ovarian cancer
Nusinersen (NUE si NER sen)
Spinraza 12-23-2016 Spinal muscular atrophy
References: 1. United States Food and Drug Administration. Novel Drug Approvals 2016.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm. Accessed January 8, 2017.