FDA Approved 46 Novel Drugs in 2017

MedCost pharmacist

By Zafeira Sarrimanolis, PharmD, MedCost Clinical Consultant

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.MedCost

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

 

 


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2 thoughts on “FDA Approved 46 Novel Drugs in 2017

  1. I had no idea that the FDA approved 46 new drugs in 2017. Also, I did not know that a novel drug is innovating and has a chemical structure that has never been approved, and usually meets a medical need that was not addressed previously. I like that you say managing drug costs will be key because the new drugs in 2018 will most likely be even more high-cost.

    • Debbie Pullen on said:

      Thank you so much for your comments, Ms. Anderson. In the current health care environment, managing drug costs assumes even higher priority.

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