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:
Regulation of copay cards
All of these strategies will be foundational in conserving costs.
Estimated Annual Cost
|11/16/17||Hemophilia A with FVIII inhibitors||$450,000|
|11/15/17||Mucopolysaccharidosis VII (MPS VII, Sly syndrome)||$375,000|
|11/14/17||Severe asthma (add-on treatment)||$30,000|
|9/14/17||Relapsed follicular lymphoma||$160,000|
|8/30/17||Acute lymphocytic leukemia||$475,000 per treatment||First gene therapy ever approved in the US|
|8/17/17||Relapsed or refractory acute lymphoblastic leukemia||$170,000
|8/1/17||Relapsed or refractory acute myeloid leukemia||$280,000
(sofosbuvir, velpatasvir, voxilaprevir)
|7/18/17||Hepatitis C||$75,000 for 3-month treatment|
|7/17/17||Reduce risk of breast cancer returning||$125,000|
|7/13/17||Moderate-to-severe plaque psoriasis
|7/7/17||Sickle cell disease||$11,000 – $18,000||Second drug approved for Sickle Cell in the US|
(C1 esterase inhibitor)
|6/7/17||Congenital fibrinogen deficiency||n/a||Pending launch date|
(coagulation factor IX)
|5/31/17||Hemophilia B||n/a||Expected launch early 2018|
|5/22/17||Rheumatoid arthritis||$39,000||Second-line agent|
|5/5/17||ALS||$145,000||Second drug ever approved for ALS|
|4/28/17||Acute myeloid leukemia||$180,000|
|$700,000||Very rare, inherited condition|
|4/11/17||Tardive dyskinesia||$64,000 – $128,000 depending on dose|
|3/28/17||Multiple sclerosis||$65,000 (~20% less than current treatments)|
|3/27/17||Epithelial ovarian, fallopian tube or primary peritoneal cancers||$160,000|
|3/23/17||Merkel cell carcinoma||$150,000|
- 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/)