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FDA Approvals in 2017

FDA Approvals in 2017

By: Jason Marcewicz  |  Content and Communications Specialist | Advanced Medical Strategies

The FDA approved 46 new molecular entities (NMEs) in 2017, the most in over two decades. (Just 22 NMEs were approved in all of 2016; the average approval rate for the past decade is about 30 per year.) This list of so-called novel drugs does not include approximately 40 drugs that were approved for additional diseases/conditions or new dosage forms/regimens. High-profile CAR-T and gene therapies were also not included in the final tally, nor were certain kinds of plasma products or medical implants & devices that got the green light as well.

Below are the high dollar specialty drugs (listed in reverse chronological order of when approved) that have been added to PredictRx and PredictDx in the 2017 calendar year—except for those with an asterisk * which were approved in 2017 but have not yet been launched.

 

Luxturna (voretigene neparvovec-rzyl) 12/19*

Ixifi (infliximab-qbtx) 12/13*

Ogivri (trastuzumab-dkst) 12/1*

Hemlibra (emicizumab-kxwh) 11/16

Mepsevii (vestronidase alfa) 11/15

Calquence (acalabrutinib) 10/31

Yescarta (axicabtagene ciloleucel) 10/18

Verzenio (abemaciclib) 9/28

Aliqopa (copanlisib) 9/14

Mvasi (bevacizumab-awwb) 9/14*

Mylotarg (gemtuzumab ozogamicin) 9/1

Kymriah (tisagenlecleucel) 8/30

Cyltezo (adalimumab-adbm) 8/25*

Besponsa (inotuzumab ozogamicin) 8/17

Mavyret (glecaprevir and pibrentasvir) 8/3

Vyxeos (cytarabine and daunorubicin) 8/3

Idhifa (enasidenib) 8/1

Vosevi (sofosbuvir, velpatasvir and voxilaprevir) 7/18

Nerlynx (neratinib) 7/17

Haegarda (C1 esterase inhibitor [human]) 6/22

Rituxan Hycela (rituximab and hyaluronidase human) 6/22

Rebinyn (coagulation factor IX [recombinant], GlycoPEGylated) 5/31

Kevzara (sarilumab) 5/22

Radicava (edaravone) 5/5

Imfinzi (durvalumab) 5/1

Rydapt (midostaurin) 4/28

Alunbrig (brigatinib) 4/28

Brineura (cerliponase alfa) 4/27

Ocrevus (ocrelizumab) 3/28

Zejula (niraparib) 3/27

Bavencio (avelumab) 3/23

Kisqali (ribociclib) 3/13

Siliq (brodalumab) 2/15

Emflaza (deflazacort) 2/9

 

Since January 1 the following high dollar specialty drugs within the Predict Suite gained FDA approval for either new indications or dosages/formulations:

 

Xeljanz (tofacitinib) 12/14

Nucala (mepolizumab) 12/12

Taltz (ixekizumab) 12/1

Repatha (evolocumab) 12/1

Sprycel (dasatinib) 11/9

Soliris (eculizumab) 10/23

Stelara (ustekinumab) 10/13

Opdivo (nivolumab) 9/22

Keytruda (pembrolizumab) 9/22

Somatuline (lanreotide acetate) 9/15

Privigen (immune globulin intravenous (human)) 9/14

Tracleer (bosentan) 9/5

Actemra (tocilizumab) 8/30

Imbruvica (ibrutinib) 8/1

Opdivo (nivolumab) 7/31

Yervoy (ipilimumab) 7/21

Benlysta (belimumab) 7/20

Blincyto (blinatumomab) 7/11

Orencia (abatacept) 7/6

Vectibix (panitumumab) 6/29

Tafinlar (dabrafenib) 6/22

Keytruda (pembrolizumab) 5/23

Actemra (tocilizumab) 5/22

Keytruda (pembrolizumab) 5/18

Bavencio (avelumab) 5/9

Stivarga (regorafenib) 4/27

Tecentriq (atezolizumab) 4/17

Lucentis (ranibizumab) 4/15

Harvoni (ledipasvir) 4/7

Sovaldi (sofosbuvir) 4/7

Humira (adalimumab) 3/27

Keytruda (pembrolizumab) 3/14

Revlimid (lenalidomide) 2/22

Opdivo (nivolumab) 2/2

Imbruvica (ibrutinib) 1/18

Lucentis (ranibizumab) 1/5

 

AMS remains steadfast in its mission to provide cutting-edge cost containment tools for the healthcare industry. Catastrophic claims can be managed effectively and efficiently by using the predictive modeling analytics within the Predict Suite of Solutions: PredictRx, PredictDx, and ImplantDx.