Table 3.
Transparency of novel drugs and biologics approved by the FDA in 2016 and 2017
| Product | Company sponsor | Product type | Trial samples | ||
| % of ‘all trials’ with public results | % of ‘patient trials’ with public results | FDAAA implementation score | |||
| Adlyxin | Sanofi | Biologic | 53 (29/55) | 96 (27/28) | 93 (13/14) |
| Aliqopa | Bayer | Drug | 100 (6/6) | 100 (3/3) | 100 (1/1) |
| Alunbrig | Takeda/Ariad | Drug | 50 (2/4) | 100 (2/2) | 100 (2/2) |
| Amjevita | Amgen | Biologic | 80 (4/5) | 100 (3/3) | 100 (3/3) |
| Austedo | Teva | Drug | 25 (2/8) | 100 (2/2) | 50 (1/2) |
| Bavencio | Merck KGaA/EMD Serono | Biologic | 100 (1/1) | NA | NA |
| Baxdela | Melinta Therapeutics | Drug | 39 (13/33) | 100 (4/4) | 25 (1/4) |
| Benznidazole | Chemo Research | Drug | 74 (23/31) | 75 (3/4) | NA |
| Besponsa | Pfizer/Wyeth | Biologic | 100 (11/11) | 100 (2/2) | 100 (2/2) |
| Bevyxxa | Portola | Drug | 25 (5/20) | 100 (4/4) | 100 (2/2) |
| Brineura | BioMarin | Biologic | 0 (0/1) | 0 (0/1) | 0 (0/1) |
| Calquence | AstraZeneca | Drug | 13 (1/8) | 100 (1/1) | 0 (0/1) |
| Cuvitru | Shire/Baxalta | Biologic | 100 (3/3) | 100 (3/3) | 50 (1/2) |
| Dupixent | Regeneron | Biologic | 53 (9/17) | 80 (8/10) | 0 (0/8) |
| Emflaza | PTC Therapeutics | Drug | 9 (1/11) | 25 (1/4) | 0 (0/2) |
| Epclusa | Gilead | Drug | 24 (8/33) | 80 (8/10) | 100 (9/9) |
| Erelzi | Novartis | Biologic | 60 (3/5) | 100 (1/1) | NA |
| Eucrisa | Pfizer/Anacor | Drug | 48 (11/23) | 83 (5/6) | 80 (4/5) |
| Fasenra | AstraZeneca | Biologic | 82 (9/11) | 82 (9/11) | 78 (7/9) |
| Giapreza | La Jolla | Drug | 33 (3/9) | 67 (2/3) | 100 (1/1) |
| Hemlibra | Roche/Genentech | Biologic | 67 (2/3) | 100 (2/2) | 100 (1/1) |
| Idhifa | Celgene | Drug | 0 (0/1) | NA | NA |
| Imfinzi | AstraZeneca | Biologic | 100 (1/1) | NA | NA |
| Ingrezza | Neurocrine Biosciences | Drug | 38 (6/16) | 100 (6/6) | 80 (4/5) |
| Kevzara | Sanofi | Biologic | 59 (13/22) | 83 (10/12) | 100 (8/8) |
| Kisqali | Novartis | Drug | 40 (4/10) | 100 (1/1) | 100 (1/1) |
| Kovaltry | Bayer | Biologic | 100 (2/2) | 100 (2/2) | 100 (2/2) |
| Lartruvo | Eli Lilly | Biologic | 89 (8/9) | 80 (4/5) | 100 (2/2) |
| Macrilen | Novo Nordisk | Drug | 57 (4/7) | 100 (2/2) | 100 (2/2) |
| Mavyret | AbbVie | Drug | 35 (15/43) | 100 (10/10) | 100 (10/10) |
| Mepsevii | Ultragenyx | Biologic | 100 (2/2) | 100 (2/2) | 100 (2/2) |
| Nerlynx | Puma Biotechnology | Drug | 80 (12/15) | 100 (6/6) | 100 (5/5) |
| Ocrevus | Roche/Genentech | Biologic | 73 (11/15) | 100 (4/4) | 100 (4/4) |
| Ozempic | Novo Nordisk | Drug | 90 (26/29) | 100 (13/13) | 86 (6/7) |
| Parsabiv | Amgen | Drug | 100 (12/12) | 100 (10/10) | 100 (9/9) |
| Prevymis | Merck Sharp & Dohme | Drug | 37 (10/27) | 100 (3/3) | 100 (2/2) |
| Radicava | Mitsubishi Tanabe | Drug | 27 (4/15) | 80 (4/5) | NA |
| Rhopressa | Aerie | Drug | 100 (9/9) | 100 (7/7) | 57 (4/7) |
| Rydapt | Novartis | Drug | 63 (12/19) | 100 (5/5) | 100 (2/2) |
| Siliq | Valeant | Biologic | 84 (16/19) | 83 (5/6) | 100 (4/4) |
| Solosec | Lupin | Drug | 88 (7/8) | 100 (3/3) | 0 (0/3) |
| Spinraza | Biogen | Drug | 100 (4/4) | 100 (4/4) | 100 (2/2) |
| Steglatro | Merck Sharp & Dohme | Drug | 54 (19/35) | 100 (10/10) | 100 (9/9) |
| Symproic | Shionogi | Drug | 100 (23/23) | 100 (7/7) | 80 (4/5) |
| Taltz | Eli Lilly | Biologic | 100 (12/12) | 100 (7/7) | 100 (6/6) |
| Tecentriq | Roche/Genentech | Biologic | 100 (6/6) | 100 (5/5) | 100 (4/4) |
| Tremfya | J&J/Janssen | Biologic | 85 (11/13) | 100 (8/8) | 80 (4/5) |
| Trulance | Synergy | Drug | 13 (1/8) | 20 (1/5) | 0 (0/5) |
| Tymlos | Radius | Drug | 27 (4/15) | 100 (4/4) | 50 (2/4) |
| Vabomere | The Medicines Company/Rempex | Drug | 67 (4/6) | 50 (1/2) | 50 (1/2) |
| Venclexta | AbbVie | Drug | 67 (4/6) | NA | NA |
| Verzenio | Eli Lilly | Biologic | 100 (16/16) | 100 (3/3) | 100 (3/3) |
| Vosevi | Gilead | Drug | 45 (9/20) | 100 (9/9) | 88 (7/8) |
| Vyzulta | Bausch Health/Bausch and Lomb | Drug | 60 (6/10) | 71 (5/7) | 0 (0/6) |
| Xadago | US Worldmeds | Drug | 34 (13/38) | 50 (7/14) | 100 (3/3) |
| Xepi | Ferrer | Drug | 35 (6/17) | 100 (3/3) | 100 (2/2) |
| Xermelo | Lexicon | Drug | 38 (5/13) | 100 (4/4) | 75 (3/4) |
| Xiidra | Shire | Drug | 100 (7/7) | 100 (5/5) | 100 (5/5) |
| Zejula | Tesaro | Drug | 100 (3/3) | 100 (2/2) | 0 (0/1) |
| Zepatier | Merck Sharp & Dohme | Drug | 27 (17/62) | 94 (16/17) | 100 (14/14) |
| Zinbryta | Biogen | Biologic | 90 (9/10) | 100 (5/5) | 100 (2/2) |
| Zinplava | Merck Sharp & Dohme | Biologic | 33 (3/9) | 75 (3/4) | 100 (2/2) |
| Median (IQR) | 62 (36–98) | 100 (83–100) | 100 (66–100) | ||
| Percentage of products fully meeting measure | 26 (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.