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
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Prior authorizations
-
Step-therapy programs
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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:
- OptumRx® RxNews
- FDA: “Novel Drug Approvals for 2017”. Accessed: https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm537040.htm
- FDA: “Drugs@FDA: FDA Approved Drug Products”. Accessed: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
- Pharmacy Times (http://www.pharmacytimes.com/)
- Specialty Pharmacy Times (https://www.specialtypharmacytimes.com/)
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