Novel Drug Approvals for 2023 (2024)

1.Leqembi

lecanemab-irmb

1/6/2023To treat Alzheimer’s disease
Press Release2.Brenzavvybexagliflozin1/20/2023To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
Drug Trials Snapshot3.Jaypircapirtobrutinib1/27/2023To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor
Drug Trials Snapshot4.Orserduelacestrant1/27/2023To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
Drug Trials Snapshot5.Jesduvroqdaprodustat2/1/2023To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
Press Release
Drug Trials Snapshot6.Lamzedevelmanase alfa-tycv2/16/2023To treat non-central nervous system manifestations of alpha-mannosidosis7.Filsparisparsentan2/17/2023To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression8.Skyclarysomaveloxolone2/28/2023To treat Friedrich’s ataxia
Drug Trials Snapshots9.Zavzpretzavegepant3/9/2023To treat migraine10.Daybuetrofinetide3/10/2023To treat Rett syndrome11.Zynyzretifanlimab-dlwr3/22/2023To treat metastatic or recurrent locally advanced Merkel cell carcinoma12.Rezzayorezafungin3/22/2023To treat candidemia and invasive candidiasis13.Joenjaleniolisib3/24/2023To treat activated phosphoinositide 3-kinase delta syndrome14.Qalsodytofersen4/25/2023To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation15.Elfabriopegunigalsidase alfa-iwxj5/9/2023To treat confirmed Fabry disease16.Veozahfezolinetant5/12/2023To treat moderate to severe hot flashes caused by menopause
Press Release17.Mieboperfluorhexyloctane5/18/2023To treat signs and symptoms of dry eye disease18.Epkinlyepcoritamab-bysp5/19/2023To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy19.Xacdurosulbactam, durlobactam5/23/2023

To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
Press Release

20.Paxlovidnirmatrelvir, ritonavir5/25/2023To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19
Press Release
Drug Trials Snapshot21.Poslumaflotufolastat F 185/25/2023To use with positron emission tomography imaging in certain patients with prostate cancer
Drug Trials Snapshot22.Inpefasotagliflozin5/26/2023

​To treat heart failure

23.Columviglofitamab-gxbm6/15/2023To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy
Drug Trials Snapshot24.Litfuloritlecitinib6/23/2023To treat severely patchy hair loss
Drug Trials Snapshot25.Rystiggorozanolixizumab-noli6/26/2023To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive26.Ngenlasomatrogon-ghla6/27/2023To treat growth failure due to inadequate secretion of endogenous growth hormone
Drug Trials Snapshot27.Beyfortusnirsevimab-alip7/17/2023To prevent respiratory syncytial virus (RSV) lower respiratory tract disease
Press Release
Drug Trials Snapshot28.Vanflytaquizartinib7/20/2023To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria
Drug Trials Snapshot29.Xdemvylotilaner7/25/2023To treat Demodex blepharitis30.Zurzuvaezuranolone8/4/2023To treat postpartum depression
Press Release31.Izervayavacincaptad pegol8/4/2023To treat geographic atrophy secondary to age-related macular degeneration32.Talveytalquetamab-tgvs8/9/2023To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies33.Elrexfioelranatamab-bcmm8/14/2023To treatadults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy34.Sohonospalovarotene8/16/2023To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva35.Veopozpozelimab-bbfg8/18/2023To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease36.Aphexdamotixafortide9/8/2023To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma
Drug Trials Snapshot37.Ojjaaramomelotinib9/15/2023To treatintermediate or high-risk myelofibrosis in adults with anemia38.Exxuagepirone9/22/2023To treat major depressive disorder39.Pombiliticipaglucosidase alfa-atga9/28/2023

To treat late-onset Pompe disease
Drug Trials Snapshot

40.Rivflozanedosiran9/29/2023To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function41.Velsipityetrasimod10/12/2023To treat moderately to severely active ulcerative colitis in adults42.Zilbrysqzilucoplan10/17/2023Totreat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive43.Bimzelxbimekizumab10/17/2023To treat moderate to severeplaque psoriasisin adults who are candidates for systemic therapy or phototherapy
Drug Trials Snapshot44.Agamreevamorolone10/26/2023To treat duch*enne muscular dystrophy
Drug Trials Snapshot45.Omvohmirikizumab-mrkz10/26/2023To treat ulcerative colitis46.Loqtorzitoripalimab-tpzi10/27/2023To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies47.Fruzaqlafruquintinib11/8/2023To treat refractory, metastatic colorectal cancer48.Defencathtaurolidine, heparin11/15/2023To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter49.Augtyrorepotrectinib11/15/2023To treat ROS1-positive non-small cell lung cancer50.Ryzneutaefbemalenograstim alfa-vuxw11/16/2023To treat neutropenia
Drug Trials Snapshot51.Truqapcapivasertib11/16/2023To treat breast cancer that meets certain disease criteria52.Ogsiveonirogacestat11/27/2023To treat adults with progressing desmoid tumors who require systemic treatment53.Fabhaltaiptacopan12/5/2023To treat paroxysmal nocturnal hemoglobinuria54.Filsuvezbirch triterpenes12/18/2023To treatwounds associated with dystrophic and junctional epidermolysis bullosa55.Wainuaeplontersen12/21/2023To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
Drug Trials Snapshot
Novel Drug Approvals for 2023 (2024)
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