Aprobaciones de fármacos por la FDA durante 2017: 46 nuevos fármacos
enero 7, 2018
|In Artículos
Durante el 2017 la FDA ha aprobado 46 nuevos fármacos, el doble que en 2016 . Si necesitas un poco de orden en Un artículo de BiopharmaDive, nos proporciona una información sobre los mismos de forma clara y detallada. Aquí están las tablas que son muy útiles y al final encontrarás el enlace al artículo completo.
TABLE 1. NEW DRUGS APPROVED FOR CANCER
Drug designation key
OD – Orphan Drug
BT – Breakthrough Therapy
PR – Priority Review
FT – Fast Track
| Drug | Date approved | Indication | Developer | Designations |
|---|---|---|---|---|
| Kisqali (ribociclib) | 3/13 | Advanced breast cancer | Novartis | |
| Bavencio (avelumab) | 3/23 | Merkel cell carcinoma | EMD Serono | OD BT PR |
| Zejula (niraparib) | 3/27 | Ovarian cancer | Tesaro | OD BT PR FT |
| Alunbrig (brigatinib) | 4/28 | Lung cancer | Ariad | OD BT |
| Rydapt (midostaurin) | 4/28 | Acute myeloid leukemia | Novartis | BT PR FT |
| Imfinzi (durvalumab) | 5/1 | Urothelial cancer | AstraZeneca | BT PR |
| Nerlynx (neratinib) | 7/17 | Early-stage breast cancer | Puma Biotech | |
| Idhifa (enasidenib) | 8/1 | Acute myeloid leukemia | Celgene | OD PR |
| Besponsa (inotuzumab ozogamicin) | 8/17 | Acute lymphoblastic leukemia | Pfizer | OD BT PR |
| Kymriah (tisagenlecleucel) | 8/30 | Acute lymphoblastic leukemia | Novartis | BT PR |
| Aliqopa (copanlisib) | 9/14 | Follicular lymphoma | Bayer | OD PR |
| Verzenio (abemaciclib) | 9/28 | Advanced breast cancer | Eli Lilly | BT PR |
| Yescarta (axicabtagene ciloleucel) | 10/18 | B-cell lymphoma | Kite Pharma | OD BT PR |
| Calquence (acalabrutinib) | 10/31 | Mantle cell lymphoma | AstraZeneca | OD BT PR |
TABLE 2. NEW DRUGS APPROVED FOR RARE DISEASES (NON-CANCER)
Drug designation key
OD – Orphan Drug
BT – Breakthrough Therapy
PR – Priority Review
FT – Fast Track
| Drug | Date approved | Indication | Developer | Designations |
|---|---|---|---|---|
| Emflaza (deflazacort) | 2/9 | Duchenne muscular dystrophy | Marathon Pharma | OD PR FT |
| Xermelo (telotristat ethyl) | 2/28 | Carcinoid syndrome diarrhea | Lexicon Pharma | OD PR FT |
| Austedo (deutetrabenazine) | 4/3 | Huntington’s disease | Teva | OD |
| Brineura (cerliponase alfa) | 4/27 | Batten disease | BioMarin | OD BT PR |
| Radicava (edaravone) | 5/5 | ALS | Mitsubishi Tanabe | OD |
| Haegarda (C1 esterase inhibitor) | 6/22 | Hereditary angioedema | CSL Behring | OD |
| benznidazole | 8/29 | Chagas disease | Chemo Research | OD PR |
| Prevymis (letermovir) | 11/8 | Cytomegalovirus prophylaxis | Merck & Co. | OD |
| Mepsevii (vestronidase alfa) | 11/15 | Sly syndrome | Ultragenyx | OD FT |
| Luxturna (voretigene neparvovec) | 12/19 | RPE65 mutation-associated retinal dystrophy | Spark | OD BT PR |
TABLE 3. NEW DRUGS APPROVED FOR INFLAMMATORY CONDITIONS
Drug designation key
BT – Breakthrough Therapy
PR – Priority Review
| Drug | Date approved | Indication | Developer | Designations |
|---|---|---|---|---|
| Siliq (brodalumab) | 2/15 | Plaque psoriasis | Valeant | |
| Dupixent (dupilumab) | 3/28 | Atopic dermatitis | Sanofi | BT PR |
| Kevzara (sarilumab) | 5/22 | Rheumatoid arthritis | Sanofi | |
| Tremfya (guselkumab) | 7/13 | Plaque psoriasis | Janssen | |
| Fasenra (benralizumab) | 11/14 | Severe asthma | AstraZeneca |
TABLE 4. OTHER NEW DRUGS APPROVED IN 2017
Drug designation key
BT – Breakthrough Therapy
PR – Priority Review
FT – Fast Track
| Drug | Date approved | Indication | Developer | Designations |
|---|---|---|---|---|
| Trulance (plecanatide) | 1/19 | Chronic idiopathic constipation | Synergy | |
| Parsabiv (etelcalcetide) | 2/7 | Secondary hyperparathyroidism | Amgen | |
| Xadago (safinamide) | 3/21 | Parkinson’s disease | Newron | |
| Symproic (naldemedine) | 3/23 | Opioid-induced constipation | Shionogi | |
| Ocrevus (ocrelizumab) | 3/28 | Multiple sclerosis | Roche | BT PR FT |
| Ingrezza (valbenazine) | 4/22 | Tardive dyskinesia | Neurocrine | BT PR FT |
| Tymlos (abaloparatide) | 4/28 | Osteoporosis | Radius Health | |
| Baxdela (delafloxacin) | 6/19 | Acute bacterial skin infections | Melinta | PR |
| Bevyxxa (betrixaban) | 6/23 | Venous thromboembolism prophylaxis | Portola | |
| Vosevi (sofosbuvir/ |
7/18 | Hepatitis C | Gilead | BT PR |
| Mavyret (glecaprevir/ |
3/28 | Hepatitis C | AbbVie | BT PR |
| Vabomere (meropenem/ |
8/29 | Urinary tract infections | Rempex | PR |
| Solosec (secnidazole) | 9/15 | Bacterial vaginosis | Lupin | PR FT |
| Shingrix (Zoster vaccine) | 10/20 | Shingles | Glaxo |
|
| Vyzulta (latanoprostene bunod) | 11/2 | Glaucoma or ocular hypertension | Valeant | |
| Heplisav-B (Hepatitis B vaccine) | 11/9 | Hepatitis B | Dynavax | |
| Ozempic (semaglutide) | 12/5 | Type 2 diabetes | Novo Nordisk | |
| Xepi (ozenoxacin) | 12/11 | Impetigo | Ferrer | |
| Rhopressa (netarsudil) | 12/18 | Glaucoma or ocular hypertension | Aerie | |
| Steglatro (ertugliflozin) | 12/19 | Type 2 diabetes | Merck & Co. | |
| Macrilen (macimorelin acetate) | 12/20 | Diagnosis of adult growth hormone deficiency | Aeterna Zentaris | |
| Giapreza (angiotensin II) | 12/21 | Low blood pressure | La Jolla | PR |
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