Guideline Central Blog

• Keytruda (Merck)New Indication
  • In combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

• Hyqvia (Takeda) Expanded Indication
  • To treat primary immunodeficiency (PI) in children 2-16 years old.

• Omisirge (Gamida Cell) 
  • In adult and pediatric patients 12 years and older with hematologic malignancies planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

• Qulipta (AbbVie) New Indication
  • Preventive treatment of migraine in adults.

• RizaFilm (IntelGenx Corp)
  • Treatment of acute migraine.

• Qalsody (Biogen) 
  • Treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

• Vowst (Seres Therapeutics/Nestlé Health Science)
  • Prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older, following antibacterial treatment for recurrent CDI.

• Trikafta (Vertex Pharmaceuticals) Expanded Indication
  • To include children with cystic fibrosis (CF) ages 2 through 5 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.

• Prevnar 20 (Pfizer) Expanded Indication
  • Prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in Prevnar.

• Sogroya (Novo Nordisk) New Indication
  • Treatment of children aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

• Abilify Asimtufii (Otsuka / Lundbeck)
  • Treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.

• Uzedy (Teva Pharmaceuticals)
  • Treatment of schizophrenia in adults.

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