Novel Drug Approvals for 2023

1. Leqembi lecanemab-irmb 1/6/2023 To treat Alzheimer’s disease
Press Release 2. Brenzavvy bexagliflozin 1/20/2023 To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
Drug Trials Snapshot 3. Jaypirca pirtobrutinib 1/27/2023 To 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 Snapshot 4. Orserdu elacestrant  1/27/2023 To 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 Snapshot 5. Jesduvroq daprodustat 2/1/2023 To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
Press Release
Drug Trials Snapshot 6. Lamzede velmanase alfa-tycv 2/16/2023 To treat non-central nervous system manifestations of alpha-mannosidosis 7. Filspari sparsentan 2/17/2023 To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
Drug Trials Snapshot 8. Skyclarys omaveloxolone 2/28/2023 To treat Friedrich’s ataxia
Drug Trials Snapshots 9. Zavzpret zavegepant 3/9/2023 To treat migraine 10. Daybue trofinetide 3/10/2023 To treat Rett syndrome
Drug Trials Snapshot 11. Zynyz retifanlimab-dlwr 3/22/2023 To treat metastatic or recurrent locally advanced Merkel cell carcinoma
Drug Trials Snapshot 12. Rezzayo rezafungin 3/22/2023 To treat candidemia and invasive candidiasis 13. Joenja leniolisib 3/24/2023 To treat activated phosphoinositide 3-kinase delta syndrome
Drug Trials Snapshots 14. Qalsody tofersen 4/25/2023 To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation 15. Elfabrio pegunigalsidase alfa-iwxj 5/9/2023 To treat confirmed Fabry disease
Drug Trials Snapshot 16. Veozah fezolinetant 5/12/2023

To treat moderate to severe hot flashes caused by menopause
Press Release
Drug Trials Snapshot

17. Miebo perfluorhexyloctane 5/18/2023 To treat signs and symptoms of dry eye disease 18. Epkinly epcoritamab-bysp 5/19/2023 To 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 therapy
Drug Trails Snapshots 19. Xacduro sulbactam, durlobactam 5/23/2023 To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
Press Release 20. Paxlovid nirmatrelvir, ritonavir 5/25/2023 To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19
Press Release
Drug Trials Snapshot 21. Posluma flotufolastat F 18 5/25/2023 To use with positron emission tomography imaging in certain patients with prostate cancer
Drug Trials Snapshot 22. Inpefa sotagliflozin 5/26/2023 To treat heart failure
Drug Trials Snapshot 23. Columvi glofitamab-gxbm 6/15/2023 To 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 Snapshot 24. Litfulo ritlecitinib 6/23/2023 To treat severely patchy hair loss
Drug Trials Snapshot 25. Rystiggo rozanolixizumab-noli 6/26/2023 To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive
Drug Trials Snapshot 26. Ngenla somatrogon-ghla 6/27/2023 To treat growth failure due to inadequate secretion of endogenous growth hormone
Drug Trials Snapshot 27. Beyfortus nirsevimab-alip 7/17/2023 To prevent respiratory syncytial virus (RSV) lower respiratory tract disease
Press Release
Drug Trials Snapshot 28. Vanflyta quizartinib 7/20/2023 To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria
Drug Trials Snapshot 29. Xdemvy lotilaner 7/25/2023 To treat Demodex blepharitis 30. Zurzuvae zuranolone 8/4/2023 To treat postpartum depression 
Press Release
Drug Trials Snapshot 31. Izervay avacincaptad pegol 8/4/2023 To treat geographic atrophy secondary to age-related macular degeneration 32. Talvey talquetamab-tgvs 8/9/2023 To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies
Drug Trials Snapshot 33. Elrexfio elranatamab-bcmm 8/14/2023 To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy
Drug Trials Snapshot 34. Sohonos palovarotene 8/16/2023 To 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 progressiva
Drug Trials Snapshot 35. Veopoz pozelimab-bbfg 8/18/2023 To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease
Drug Trials Snapshot 36. Aphexda motixafortide 9/8/2023 To 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 Snapshot 37. Ojjaara momelotinib 9/15/2023 To treat intermediate or high-risk myelofibrosis in adults with anemia 38. Exxua gepirone 9/22/2023 To treat major depressive disorder 39. Pombiliti cipaglucosidase alfa-atga 9/28/2023 To treat late-onset Pompe disease
Drug Trials Snapshot 40. Rivfloza nedosiran 9/29/2023 To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function
Drug Trials Snapshot 41. Velsipity etrasimod 10/12/2023 To treat moderately to severely active ulcerative colitis in adults
Drug Trials Snapshot 42. Zilbrysq zilucoplan 10/17/2023 To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
Drug Trials Snapshot 43. Bimzelx bimekizumab 10/17/2023 To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Drug Trials Snapshot 44. Agamree vamorolone 10/26/2023 To treat Duchenne muscular dystrophy
Drug Trials Snapshot 45. Omvoh mirikizumab-mrkz 10/26/2023 To treat ulcerative colitis
Drug Trials Snapshot 46. Loqtorzi toripalimab-tpzi 10/27/2023 To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies 47. Fruzaqla fruquintinib 11/8/2023 To treat refractory, metastatic colorectal cancer
Drug Trials Snapshot 48. Defencath taurolidine, heparin 11/15/2023 To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter
Drug Trials Snapshot 49. Augtyro repotrectinib 11/15/2023 To treat ROS1-positive non-small cell lung cancer
Drug Trials Snapshot 50. Ryzneuta efbemalenograstim alfa-vuxw 11/16/2023 To treat neutropenia
Drug Trials Snapshot 51. Truqap capivasertib 11/16/2023 To treat breast cancer that meets certain disease criteria 52. Ogsiveo nirogacestat 11/27/2023 To treat adults with progressing desmoid tumors who require systemic treatment
Drug Trials Snapshot 53. Fabhalta  iptacopan 12/5/2023 To treat paroxysmal nocturnal hemoglobinuria 54. Filsuvez birch triterpenes 12/18/2023 To treat wounds associated with dystrophic and junctional epidermolysis bullosa
Drug Trials Snapshot 55. Wainua eplontersen 12/21/2023 To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
Drug Trials Snapshot

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