Table 3

Transparency of novel drugs and biologics approved by the FDA in 2016 and 2017

ProductCompany sponsorProduct typeTrial samples
% of ‘all trials’ with public results% of ‘patient trials’ with public resultsFDAAA implementation score
AdlyxinSanofiBiologic53 (29/55)96 (27/28)93 (13/14)
AliqopaBayerDrug100 (6/6)100 (3/3)100 (1/1)
AlunbrigTakeda/AriadDrug50 (2/4)100 (2/2)100 (2/2)
AmjevitaAmgenBiologic80 (4/5)100 (3/3)100 (3/3)
AustedoTevaDrug25 (2/8)100 (2/2)50 (1/2)
BavencioMerck KGaA/EMD SeronoBiologic100 (1/1)NANA
BaxdelaMelinta TherapeuticsDrug39 (13/33)100 (4/4)25 (1/4)
BenznidazoleChemo ResearchDrug74 (23/31)75 (3/4)NA
BesponsaPfizer/WyethBiologic100 (11/11)100 (2/2)100 (2/2)
BevyxxaPortolaDrug25 (5/20)100 (4/4)100 (2/2)
BrineuraBioMarinBiologic0 (0/1)0 (0/1)0 (0/1)
CalquenceAstraZenecaDrug13 (1/8)100 (1/1)0 (0/1)
CuvitruShire/BaxaltaBiologic100 (3/3)100 (3/3)50 (1/2)
DupixentRegeneronBiologic53 (9/17)80 (8/10)0 (0/8)
EmflazaPTC TherapeuticsDrug9 (1/11)25 (1/4)0 (0/2)
EpclusaGileadDrug24 (8/33)80 (8/10)100 (9/9)
ErelziNovartisBiologic60 (3/5)100 (1/1)NA
EucrisaPfizer/AnacorDrug48 (11/23)83 (5/6)80 (4/5)
FasenraAstraZenecaBiologic82 (9/11)82 (9/11)78 (7/9)
GiaprezaLa JollaDrug33 (3/9)67 (2/3)100 (1/1)
HemlibraRoche/GenentechBiologic67 (2/3)100 (2/2)100 (1/1)
IdhifaCelgeneDrug0 (0/1)NANA
ImfinziAstraZenecaBiologic100 (1/1)NANA
IngrezzaNeurocrine BiosciencesDrug38 (6/16)100 (6/6)80 (4/5)
KevzaraSanofiBiologic59 (13/22)83 (10/12)100 (8/8)
KisqaliNovartisDrug40 (4/10)100 (1/1)100 (1/1)
KovaltryBayerBiologic100 (2/2)100 (2/2)100 (2/2)
LartruvoEli LillyBiologic89 (8/9)80 (4/5)100 (2/2)
MacrilenNovo NordiskDrug57 (4/7)100 (2/2)100 (2/2)
MavyretAbbVieDrug35 (15/43)100 (10/10)100 (10/10)
MepseviiUltragenyxBiologic100 (2/2)100 (2/2)100 (2/2)
NerlynxPuma BiotechnologyDrug80 (12/15)100 (6/6)100 (5/5)
OcrevusRoche/GenentechBiologic73 (11/15)100 (4/4)100 (4/4)
OzempicNovo NordiskDrug90 (26/29)100 (13/13)86 (6/7)
ParsabivAmgenDrug100 (12/12)100 (10/10)100 (9/9)
PrevymisMerck Sharp & DohmeDrug37 (10/27)100 (3/3)100 (2/2)
RadicavaMitsubishi TanabeDrug27 (4/15)80 (4/5)NA
RhopressaAerieDrug100 (9/9)100 (7/7)57 (4/7)
RydaptNovartisDrug63 (12/19)100 (5/5)100 (2/2)
SiliqValeantBiologic84 (16/19)83 (5/6)100 (4/4)
SolosecLupinDrug88 (7/8)100 (3/3)0 (0/3)
SpinrazaBiogenDrug100 (4/4)100 (4/4)100 (2/2)
SteglatroMerck Sharp & DohmeDrug54 (19/35)100 (10/10)100 (9/9)
SymproicShionogiDrug100 (23/23)100 (7/7)80 (4/5)
TaltzEli LillyBiologic100 (12/12)100 (7/7)100 (6/6)
TecentriqRoche/GenentechBiologic100 (6/6)100 (5/5)100 (4/4)
TremfyaJ&J/JanssenBiologic85 (11/13)100 (8/8)80 (4/5)
TrulanceSynergyDrug13 (1/8)20 (1/5)0 (0/5)
TymlosRadiusDrug27 (4/15)100 (4/4)50 (2/4)
VabomereThe Medicines Company/RempexDrug67 (4/6)50 (1/2)50 (1/2)
VenclextaAbbVieDrug67 (4/6)NANA
VerzenioEli LillyBiologic100 (16/16)100 (3/3)100 (3/3)
VoseviGileadDrug45 (9/20)100 (9/9)88 (7/8)
VyzultaBausch Health/Bausch and LombDrug60 (6/10)71 (5/7)0 (0/6)
XadagoUS WorldmedsDrug34 (13/38)50 (7/14)100 (3/3)
XepiFerrerDrug35 (6/17)100 (3/3)100 (2/2)
XermeloLexiconDrug38 (5/13)100 (4/4)75 (3/4)
XiidraShireDrug100 (7/7)100 (5/5)100 (5/5)
ZejulaTesaroDrug100 (3/3)100 (2/2)0 (0/1)
ZepatierMerck Sharp & DohmeDrug27 (17/62)94 (16/17)100 (14/14)
ZinbrytaBiogenBiologic90 (9/10)100 (5/5)100 (2/2)
ZinplavaMerck Sharp & DohmeBiologic33 (3/9)75 (3/4)100 (2/2)
Median (IQR)62 (36–98)100 (83–100)100 (66–100)
Percentage of products fully meeting measure26 (16/62)67 (39/58)58 (32/55)
  • Rempex is a subsidiary of The Medicines Company, which was acquired by Novartis in 2020, after our study was completed. Amgen sponsored trials for Siliq. Chugai Pharmaceutical, a Roche subsidiary, sponsored trials for Ocrevus and Hemlibra. Bayer and AiCuris sponsored trials for Prevymis. MassBiologics and Medarex sponsored a trial for Zinplava. Sanofi sponsored trials for Dupixent. Regeneron sponsored trials for Kevzara. Aetna Zentaris sponsored trials for Macrilen. Lartruvo was withdrawn from the market in 2019. Acerta Pharma B.V., of which AstraZeneca owns a majority stake, sponsored all trials for Calquence. More data on the trial samples and products are in online supplemental tables 2–4.

  • FDAAA, Food and Drug Administration Act; NA, not applicable.