List of drugs granted breakthrough therapy designation
Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough therapy can be awarded for multiple indications.
2023[edit]
| Brand name | Manufacturer | Indication |
|---|---|---|
| Elrexfio | To treat relapsed or refractory multiple myeloma after at least four lines of therapy[1] | |
| Fabhalta | To treat paroxysmal nocturnal hemoglobinuria[1] | |
| Izervay | To treat geographic atrophy secondary to age-related macular degeneration[1] | |
| Leqembi | To treat Alzheimer's disease[1] | |
| Loqtorzi | To treat recurrent or metastatic nasopharyngeal carcinoma with or following other therapies[1] | |
| Ogsiveo | To treat desmoid tumors[1] | |
| Pombiliti | To treat late-onset Pompe disease with miglustat[1] | |
| Rivfloza | To lower urinary oxalate levels in primary hyperoxaluria type 1 and relatively preserved kidney function[1] | |
| Talvey | To treat relapsed or refractory multiple myeloma after at least four therapies[1] |
2022[edit]
2021[edit]
2020[edit]
2019[edit]
2018[edit]
2017[edit]
2016[edit]
2015[edit]
2014[edit]
2013[edit]
| Drug | Manufacturer | Indication |
|---|---|---|
| Obinutuzumab[2] | Genentech | chronic lymphocytic leukemia |
| Ibrutinib[2] | Pharmacyclics | mantle cell lymphoma |
| Sofosbuvir[2] | Gilead Sciences | Hepatitis C |
References[edit]
- ^ a b c d e f g h i New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
This article incorporates text from this source, which is in the public domain.
- ^ a b c d e f g h i j k l m n o p q r s t u v w x y z aa ab ac ad ae af ag ah ai aj ak al am an ao ap aq ar as at au av aw ax ay az ba bb bc bd be bf bg bh bi bj bk bl bm bn bo bp bq br bs bt bu bv bw bx by bz ca cb cc cd ce cf cg ch ci cj ck cl cm cn co cp cq cr cs ct cu cv cw cx cy cz da db dc dd de df dg dh di dj dk dl dm dn do dp dq dr ds dt du dv dw dx dy dz ea eb ec ed ee ef eg eh ei ej ek el em en eo ep eq er es et eu ev ew ex ey ez fa fb fc fd fe ff fg fh fi "CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2022" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on December 8, 2019. Retrieved June 25, 2023. This article incorporates text from this source, which is in the public domain.
- ^ a b "Breakthrough Therapy Approvals". U.S. Food and Drug Administration (FDA). 2020-10-08. Archived from the original on 2023-06-11. Retrieved 2023-06-25.
- ^ "FDA grants Breakthrough Therapy Designation for Roche's balovaptan in autism spectrum disorder". Roche. Retrieved 2024-04-08.
- ^ "Approval report" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 2019-04-24. Retrieved 2019-06-12.
