Guideline Central Blog

• Vafseo (Akebia Therapeutics)
  • Treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

• Ixinity (Medexus Pharmaceuticals)Expanded Indication
  • For the on-demand, prophylactic, and perioperative treatment of pediatric patients under 12 years of age with hemophilia B.

• Winrevair (Merck) 
  • Treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.

• Ultomiris (Alexion)Expanded Indication 
  • Expanded to include treatment of adults with anti–aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).

• Opsynvi (Janssen)
  • For chronic treatment of adult patients with pulmonary arterial hypertension (PAH), World Health Organization Group I and WHO functional classes II and III.

• Nexletol / Nexlizet (Esperion)Expanded Indication
  • To prevent heart attacks and cardiovascular procedures in both primary- and secondary-prevention patients regardless of statin use.

• Duvyzat (Italfarmaco)
  • Treatment of Duchenne muscular dystrophy (DMD) in patients aged 6 years or older.

• Tryvio (Idorsia)
  • To lower blood pressure, in combination with other antihypertensive agents, in adults with treatment-resistant hypertension.

• Iclusig (Takeda) New Indication
  • Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

• Edurant PED (Janssen)
  • Treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) at least 2 years of age and weighing at least 14 kg and less than 25 kg.

• Spevigo (Boehringer Ingelheim) Expanded Indication
  • Treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing ≥40 kg.

• Lenmeldy (Orchard Therapeutics)
  • Treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD).

• Xhance (Optinose) New Indication
  • Treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.

• Breyanzi (Bristol Myers Squibb)New Indication 
  • Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.

• Tevimbra (BeiGene)
  • As second-line monotherapy for certain adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

• Rezdiffra (Madrigal Pharmaceuticals)
  • Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis.

• Livmarli (Mirum Pharmaceuticals)
  • Treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC).

• Praluent (Regeneron)New Indication
  • As an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH).

• Wegovy (Novo Nordisk)New Indication
  • For reducing cardiovascular risk in adults with overweight or obesity and established cardiovascular disease.

• Opdivo (Bristol Myers Squibb) New Indication
  • In Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma.

• Brukinsa (BeiGene)New Indication
  • Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy.

• Tyenne (Fresenius Kabi)Biosimilar to Actemra
  • Multiple as biosimilar to Actemra.

• Besponsa (Pfizer) Expanded Indication
  • To include children aged ≥ 1 year with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

• Juvéderm Voluma XC (Allergan Aesthetics)New Indication 
  • For injection in the temple region to improve moderate to severe temple hallowing in individuals over the age of 21.

• Jubbonti (Sandoz) Biosimilar to Prolia
  • Multiple as biosimilar to Prolia.

• Wyost (Sandoz) Biosimilar to Xgeva
  • Multiple as biosimilar to Xgeva.

• Definity (Lantheus)
  • As an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms.

• Letybo (Hugel America)
  • To treat moderate-to-severe glabellar (frown) lines in adults.

• Rybrevant (Janssen)Expanded Indication
  • First-line use in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

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