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FDA Approved 46 Novel Drugs in 2017

Zafeira Sarrimanolis
Zafeira Sarrimanolis, PharmD, MedCost Clinical Consultant

FDA Approved 46 Novel Drugs in 2017

In 2016 we saw 22 brand-new novel drugs hit the market. This year the FDA has approved 46 novel drugs.

A novel drug is an innovative product with a chemical structure that has never been FDA approved before and usually meets a previously unmet medical need.

In 2017, these novel drug approvals were accompanied by an influx of specialty and brand-name drugs to the market – many treating common chronic conditions like diabetes, asthma and RA.

It is a very exciting time in the healthcare world as these new drugs significantly advance patient care. However, these treatments come at a cost… literally.

This is not a comprehensive list of new-to-market drugs, and does not include all 46 novel drugs, but is a snapshot of key 2017 FDA approvals.

It is hard to predict what the FDA and drug manufacturers will do in 2018. However, we should expect even more high-cost drugs to be approved and available for members.

Hopefully these will be accompanied by the influx of generics and biosimilars to the market – which may help off-set rising drug costs.

One thing we know for sure is that managing drug costs will continue to be key. We employ cost-management strategies such as:

  • Formulary management

  • Prior authorizations

  • Step-therapy programs

  • Regulation of copay cards

All of these strategies will be foundational in conserving costs.

Drug
Approval Date
Approved Use(s)
Estimated Annual Cost
Notes
Hemlibra

 

(emicizumab)

11/16/17 Hemophilia A with FVIII inhibitors $450,000  
Mepsevii

 

(vestronidase alfa-vjbk)

11/15/17 Mucopolysaccharidosis VII (MPS VII, Sly syndrome) $375,000  
Fasenra

 

(benralizumab)

11/14/17 Severe asthma (add-on treatment) $30,000  
Yescarta

 

(axicabtagene ciloleucel)

10/18/17 B-cell lymphoma $370,000  
Verzenio

 

(abemaciclib)

9/28/17 Breast cancer $130,000  
Aliqopa

 

(copanlisib)

9/14/17 Relapsed follicular lymphoma $160,000  
Kymriah

 

(tisagenlecleucel)

8/30/17 Acute lymphocytic leukemia $475,000 per treatment First gene therapy ever approved in the US
Bespona

 

(inotuzumab ozogamicin)

8/17/17 Relapsed or refractory acute lymphoblastic leukemia $170,000

 

 

 
Idhifa

 

(enasidenib)

8/1/17 Relapsed or refractory acute myeloid leukemia $280,000

 

 

 
Vosevi

 

(sofosbuvir, velpatasvir, voxilaprevir)

7/18/17 Hepatitis C $75,000 for 3-month treatment  
Nerlynx

 

(neratinib maleate)

7/17/17 Reduce risk of breast cancer returning $125,000  
Tremfya

 

(guselkumab)

7/13/17 Moderate-to-severe plaque psoriasis

 

 

$58,000  
Endari

 

(L-gultamine)

7/7/17 Sickle cell disease $11,000 – $18,000 Second drug approved for Sickle Cell in the US
Haegarda

 

(C1 esterase inhibitor)

6/22/17 Hereditary angioedema $400,000  
Fibryna

 

(fibrinogen)

6/7/17 Congenital fibrinogen deficiency n/a Pending launch date
Rebinyn

 

(coagulation factor IX)

5/31/17 Hemophilia B n/a Expected launch early 2018
Kevzara

 

(sarilumab)

5/22/17 Rheumatoid arthritis $39,000 Second-line agent
Radicava

 

(edaravone)

5/5/17 ALS $145,000 Second drug ever approved for ALS
Ryadapt

 

(midostaurin)

4/28/17 Acute myeloid leukemia $180,000  
Brineura

 

(cerliponase alfa)

4/27/17 Batten disease

 

 

$700,000 Very rare, inherited condition
Ingrezza

 

(valbenazine)

4/11/17 Tardive dyskinesia $64,000 – $128,000 depending on dose  
Ocrevus

 

(ocrelizumab)

3/28/17 Multiple sclerosis $65,000 (~20% less than current treatments)  
Dupixent

 

(dupilumab)

3/28/17 Moderate-to-severe eczema $37,000  
Zejula

 

(niraparid)

3/27/17 Epithelial ovarian, fallopian tube or primary peritoneal cancers $160,000  
Bavencio

 

(avelumab)

3/23/17 Merkel cell carcinoma $150,000  
Kisqali

 

(ribociclib)

3/13/17 Breast cancer $130,000

 

 

 

Key sources:

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