2020년 FDA 신규 승인 의약품
제약-바이오 섹터/섹터
2021. 1. 11. 06:49
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2020년 FDA 신규 승인 의약품 목록 및 Fierce Biotech (FB)과 Evaluate Pharma (EP)의 최대 연매출 전망치 정리.
| 심볼 | 기업명 | 제품명 | 성분명 | 적응증 | 승인일 | FB | EP | 시총 ($) |
| BPMC | Blueprint Medicines Corp | Ayvakit | avapritinib | gastrointestinal stromal tumor (GIST) | 2020-01-09 | $308M | $918M | 6.0B |
| HZNP | Horizon Therapeutics PLC | Tepezza | teprotumumab-trbw | Thyroid eye disease | 2020-01-21 | >$3B | $484M | 17.6B |
| EPZM | Epizyme Inc | Tazverik | tazemetostat | epithelioid sarcoma | 2020-01-23 | $500M-$1B | $556M | 1.3B |
| MRK | Merck | Dificid | fidaxomicin | C. difficile treatment in children | 2020-01-27 | $168M | 210.1B | |
| NSRGY | Nestle ADR (Aimmune) | Palfozia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | peanut allergy. | 2020-01-31 | $1.28B | $1.312B | |
| Braintree Laboratories | Pizensy | lactitol | chronic idiopathic constipation (CIC) in adults | 2020-02-12 | ||||
| AGRX | Agile Therapeutics | Twirla | levonorgestrel and ethinyl estradiol | contraceptive patch | 2020-02-14 | $216M | 250.1M | |
| BXRX | Baudax Bio Inc | Anjeso | Intravenous meloxicam | moderate to severe pain | 2020-02-20 | 49.9M | ||
| ESPR | Esperion Therapeutics Inc | Nexletol | bempedoic acid | High LDL cholesterol | 2020-02-21 | $2B-3B | $958M | 865.6M |
| HLUKF | H. Lundbeck A/S- ADR | Vypeti | eptinezumab-jjmr | Migraine | 2020-02-22 | $800M | $404M | 41.0B |
| TEVA | Teva Pharmaceutical Industries Ltd | Vypeti | eptinezumab-jjmr | Migraine | 2020-02-22 | $800M | $404M | 38.0B |
| EBR:ACPH | Acacia Pharma Group PLC | Barhemsys | Amisulpride | Barhemsys | 2020-02-27 | NA | $103M | 264.3M |
| BHVN | Biohaven Pharmaceutical Holding Co Ltd | Nurtec ODT | rimegepant | Migraine | 2020-02-27 | $1B | $868M | 5.1B |
| SNY | Sanofi SA | Sarclisa | Isatuximab | Multiple myeloma | 2020-03-02 | $3.4B | $516M | 122.0B |
| RCDTF | Recordati Industria Chimica e Farma SpA | Isturisa | Osilodrostat | Cushing's disease | 2020-03-06 | NA | $40M | 8.7B |
| ABBV | AbbVie | Durysta | bimatoprost implant | open-angle glaucoma (OAG) or ocular hypertension (OHT) | 2020-03-06 | $124M | 189.4B | |
| NVS | Novartis AG | Isturisa | osilodrostat | adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease | 2020-03-06 | $40M | 232.0B | |
| BMY | Bristol Myers Squibb (Celgene) | Zeposia | Ozanimod | Relapsing multiple sclerosis | 2020-03-26 | $1.6B-5B | $966M | 141.2B |
| XLRN | Acceleron | Reblozyl | 2020-04-06 | $1.715B | 7.0B | |||
| BMY | Bristol-Myers Squibb Co | Reblozyl | 2020-04-06 | $1.715B | 141.2B | |||
| AZN | AstraZeneca | Koselugo | Selumetinib | Neurofibromatosis type 1 | 2020-04-10 | $700M | $84M | 133.5B |
| MRK | Merck | Koselugo | Selumetinib | Neurofibromatosis type 1 | 2020-04-10 | $700M | $84M | 210.1B |
| URGN | Urogen | Jelmyto | mitomycin gel | 2020-04-15 | $133M | 464.0M | ||
| SGEN | Seagen Inc | Tukysa | tucatinib | HER-2 positive metastatic breast cancer | 2020-04-17 | $1.6B | $950M | 32.0B |
| INCY | Incyte Corp | Pemazyre | Pemigatinib | Bile duct cancer | 2020-04-17 | $140M | $335M | 20.5B |
| GILD | Gilead Sciences (Immunomedics) | Trodelvy | sacituzumab govitecan-hziy | Triple-negative breast cancer | 2020-04-22 | $1.5-5B | $2.151B | 79.0B |
| NBIX | Neurocrine Biosciences, Inc. | Ongentys | opicapone | Parkinson’s disease “off” episodes | 2020-04-27 | $150M | $344M | 10.5B |
| NVS | Novartis AG | Tabrecta | Capmatinib | Metastatic non-small cell lung cancer with MET exon 14 skipping mutations | 2020-05-06 | $1.5B | $355M | 232.0B |
| LLY | Eli Lilly And Co | Retevmo | Selpercatinib | RET-positive lung and thyroid cancers | 2020-05-11 | >$1B | $1.172B | 159.2B |
| DCPH | Deciphera Pharmaceuticals Inc | Qinlock | ripretinib | Gastrointestinal stromal tumors, or GIST | 2020-05-15 | $1.6B | $1.311B | 3.2B |
| Zionexa | Cerianna | fluoroestrdiol F18 | Diagnostic imaging agent for certain patients with breast cancer | 2020-05-20 | ||||
| AQST | Aquestive Therapeutics | Kynmobi | apomorphine sublingual film | 2020-05-22 | $189M | 179.9M | ||
| EVFM | Evofem biosciences | Phexxi | Amphora vaginal pH regulator | 2020-05-22 | $541M | 207.3M | ||
| Amivas | Artesunate | Artesunate | Malaria | 2020-05-26 | NA | NA | ||
| Avid Radiopharmaceuticals | Tauvid | flortaucipir F18 | Diagnostic agent for patients with Alzheimer’s disease | 2020-05-28 | ||||
| MNLO | Menlo Therapeutics | Zilxi | 1.5% minocycline topical foam, | Rosacea | 2020-05-29 | $112M | ||
| ABBV | AbbVie | Oriahnn | elagolix, estradiol and norethindrone acetate | uterine leiomyomas (fibroids) | 2020-05-29 | $510M | 189.4B | |
| VIE | Viela Bio Inc | Uplizna | inebilizumab-cdon | Neuromyelitis optica spectrum disorder (NMOSD) | 2020-06-11 | $500M | $518M | 2.2B |
| JAZZ | Jazz Pharmaceuticals and PharmaMar | Zepzelca | Lurbinectedin | Small cell lung cancer | 2020-06-15 | $593M | $397M | 9.0B |
| PHMMF | PharmaMar SA | Zepzelca | Lurbinectedin | Small cell lung cancer | 2020-06-15 | $593M | $397M | 1.4B |
| ZGNX | Zogenix | Fintepla | Dravet | 2020-06-15 | $369M | 1.2B | ||
| EVOK | Evoke Pharma | Gimoti | acute and recurrent diabetic gastroparesis | 2020-06-19 | $72M | 67.8M | ||
| RARE | Ultragenyx Pharmaceutical Inc | Dojolvi | triheptanoin | Long-chain fatty acid oxidation disorders | 2020-06-30 | $290M | $268M | 9.9B |
| EBR:ACPH | Acacia Pharma Group PLC | Byfavo | Remimazolam | Moderate sedation | 2020-07-02 | NA | $269M | 264.3M |
| ViiV Healthcare | Rukobia | Fostemsavir | HIV | 2020-07-02 | $285M | $282M | ||
| Astex Pharmaceuticals | Inqovi | Decitabine and cedazuridine | Intermediate- and high-risk myelodysplastic syndromes and chronic myelomonocytic leukemia | 2020-07-07 | $63M | $77M | ||
| Otsuka Pharmaceutical | Inqovi | decitabine and cedazuridine | adult patients with myelodysplastic syndromes | 2020-07-07 | $77M | |||
| Osmotica Pharmaceuticals | Upneeq | oxymetazoline hydrochloride ophthalmic solution | 2020-07-09 | $309M | ||||
| JAZZ | Jazz Pharmaceuticals PLC | Zepzelca | lurbinectedin | metastatic small cell lung cancer | 2020-07-15 | $397M | 9.0B | |
| JAZZ | Jazz Pharmaceuticals PLC | Xywav | calcium, magnesium, potassium, and sodium oxybates | cataplexy or excessive daytime sleepiness (EDS) | 2020-07-21 | $420M | 9.0B | |
| GILD | Gilead Sciences | Tecartus | Brexucabtagene autoleucel | Mantle cell lymphoma | 2020-07-24 | NA | 79.0B | |
| RDY | Dr.Reddy's Laboratories Ltd | Xeglyze | Abametapir | Head lice infestation | 2020-07-27 | NA | 11.9B | |
| MOR | Morphosys Ag | Monjuvi | tafasitamab-cxix | relapsed or refractory diffuse large B-cell lymphoma | 2020-07-31 | $1B | $687M | 3.3B |
| INCY | Incyte Corp | Monjuvi | tafasitamab-cxix | relapsed or refractory diffuse large B-cell lymphoma | 2020-07-31 | $1B | $687M | 20.5B |
| GSK | GlaxoSmithKline plc | Blenrep | Belantamab mafodotin | Multiple myeloma | 2020-08-05 | $1.2B-1.6B | $1.262B | 96.4B |
| BAYRY | Bayer AG | Lampit | Nifurtimox | Chagas disease | 2020-08-06 | NA | ||
| PTCT | PTC Therapeutics, Inc. | Evrysdi | risdiplam | spinal muscular atrophy | 2020-08-07 | $2.5B-3B | $1.786B | 4.6B |
| TRVN | Trevena Inc | Olinvyk | oliceridine | acute pain in certain adults | 2020-08-07 | $300M-400M | $226M | 376.9M |
| RHHBY | Roche Holdings AG Basel ADR Common Stock | Evrysdi | risdiplam | spinal muscular atrophy | 2020-08-07 | $1.786B | 293.3B | |
| Nippon Shinyaku Pharma | Viltepso | viltolarsen | Duchenne muscular dystrophy | 2020-08-12 | NA | $585M | ||
| RHHBY | Roche Holdings AG Basel ADR Common Stock | Enspryng | Satralizumab-mwge | Neuromyelitis optica spectrum disorder (NMOSD) | 2020-08-14 | $900M | $419M | 293.3B |
| SWX:SKIN | Cassiopea | Winlevi | Clascoterone cream 1% | Acne | 2020-08-27 | $400M | $420M | |
| NVO | Novo Nordisk A/S | Sogroya | somapacitan-beco | Adult growth hormone deficiency | 2020-08-28 | NA | $326M | 127.1B |
| BMY | Bristol Myers Squibb (Celgene) | Onureg | azacitidine tablets | AML | 2020-09-01 | $466M | ||
| RadioMedix Inc | Detectnet | copper Cu 64 dotatate injection | To help detect certain types of neuroendocrine tumors | 2020-09-03 | ||||
| BPMC | Blueprint Medicines Corp | Gavreto | pralsetinib | non-small lung cancer | 2020-09-04 | $900M | $109M | 6.0B |
| ETON | Eton Pharmaceuticals | Alkindi Sprinkle | hydrocortisone | replacement therapy in pediatric patients with adrenocortical insufficiency | 2020-09-30 | $266M | 202.7M | |
| REGN | Regeneron Pharmaceuticals Inc | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | ebola virus | 2020-10-14 | NA | 53.2B | |
| GILD | Gilead Sciences, Inc. | Veklury | remdesivir | COVID-19 | 2020-10-22 | $3B | $1.729B | 79.0B |
| KALA | Kala Pharmaceuticals | Eysuvis | 2.5 mg/mL loteprednol etabonate ophthalmic suspension | dry eye disease | 2020-10-26 | $1.118B | 426.7M | |
| EIGR | Eiger Biopharmaceuticals Inc | Zokinvy | Lonafarnib | Hutchinson-Gilford Progeria Syndrome (HGPS) | 2020-11-20 | NA | $99M | 380.0M |
| ALNY | Alnylam Pharmaceuticals, Inc. | Oxlumo | Lumasiran (ALN-GO1) | Primary Hyperoxaluria Type 1 (PH1) | 2020-11-24 | $500M | $253M | 17.0B |
| YMAB | Y-mAbs Therapeutics, Inc | Danyelza | Naxitamab | Relapsed/Refractory High-Risk Neuroblastoma | 2020-11-25 | $291M | $247M | 2.1B |
| RYTM | Rhythm Pharmaceuticals Inc | Imcivree | Setmelanotide | POMC deficiency obesity / Leptin Receptor Deficiency Obesity | 2020-11-27 | NA | $955M | 1.5B |
| Ridgeback Biotherapeutics | Ebanga | Ansuvimab-zykl | Zaire ebolavirus | 2020-12-01 | NA | |||
| BCRX | BioCryst Pharmaceuticals, Inc. | Orladeyo | Berotralstat | Hereditary angioedema | 2020-12-03 | $300M | $385M | 1.4B |
| LPCN | Lipocine Inc | Tlando | Men with low testosterone (Low T) | 2020-12-09 | $987M | 101.2M | ||
| BME:ALM | Almirall SA | Klisyri | Tirbanibulin | Actinic keratosis of the face and scalp | 2020-12-14 | $305M (€250M) | $132M | 2.0B |
| ATNX | Athenex Inc | Klisyri | Tirbanibulin | Actinic keratosis of the face and scalp | 2020-12-14 | $305M (€250M) | $132M | 1.1B |
| MGNX | MacroGenics Inc | Margenza | Margetuximab | Metastatic breast cancer | 2020-12-16 | $87M | $179M | 1.2B |
| ZLAB | Zai Lab Ltd - ADR | Margenza | Margetuximab | Metastatic breast cancer | 2020-12-16 | $87M | 12.8B | |
| MYOV | Myovant Sciences Ltd | Orgovyx | Relugolix | Advanced prostate cancer | 2020-12-18 | $1B | 2.2B | |
| UROV | Urovant Sciences Ltd | Gemtesa | Vibegron | Overactive bladder disorder | 2020-12-23 | $1.25B-1.6B |
출처
https://www.fiercebiotech.com/special-report/2020-s-new-drug-approvals
https://www.evaluate.com/vantage/articles/news/us-fda-approval-tracker-first-aimmune
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-february
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-march
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-april
https://www.evaluate.com/vantage/articles/news/us-fda-approval-tracker-several-early-decisions-may
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-june
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-july
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-august
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-september
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-october-0
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-november-0
https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-december-0
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