New Clinical Guidelines & FDA Drug Approvals – February 2023

March 2, 2023 Guideline Central

  • Jesduvroq (GlaxoSmithKline)
    • Treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.
  • Trodelvy (Gilead) New Indication
    • For patients with unresectable, locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.
  • Takhzyro (Takeda) Expanded Indication
    • For prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age (in addition to children 6 to <12).
  • Eylea (Regeneron) New Indication
    • To treat preterm infants with retinopathy of prematurity (ROP).
  • Cibinqo (Pfizer) Expanded Indication
    • For atopic dermatitis, to include adolescents aged 12 through 17 years.
  • Lamzede (Chiesi)
    • Treatment of non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients.
  • Syfovre (Apellis Pharmaceuticals)
    • Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
  • Filspari (Travere Therapeutics)
    • To reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
  • Austedo XR (Teva Pharmaceuticals) New Formulation
    • In adults for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).
  • Altuviiio (Sanofi)
    • Factor VIII replacement therapy for adults and children with hemophilia A.
  • Skyclarys (Reata Pharmaceuticals)
    • Treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
  • Kevzara (Sanofi / Regeneron) New Indication
    • Treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

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