Guideline Central Blog

• Ingrezza Sprinkle (Neurocrine Biosciences) New Formulation
  • Treatment of adults with tardive dyskinesia and chorea associated with Huntington’s disease.
• Lumify (Bausch + Lomb) Now OTC
  • Over-the-counter preservative-free eye drop with low-dose OTC brimonidine tartrate for the treatment of ocular redness due to minor eye irritations.
• Xolremdi (X4 Pharmaceuticals) 
  • For use in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.
• Libervant (Aquestive Therapeutics)
  • For the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy between 2 to 5 years of age.
• Hercessi (Accord BioPharma) Biosimilar to Herceptin
  • Biosimilar to Herceptin®, to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.
• Beqvez (Pfizer)
  • For the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test
• Pivya (Utility Therapeutics)
  • Treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
• Anktiva (ImmunityBio)
  • For the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
• Entyvio (Takeda) New Formulation
  • For maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) vedolizumab.
• Alecensa (Genentech) New Indication
  • For adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.
• Lumisight (Lumicell) 
  • For use as fluorescence imaging in adult patients with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
• Selarsdi (Teva / Alvotech) Biosimilar to Stelara
  • As a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.
• Xcopri (SK Life Science) New Formulation
  • For adults with partial-onset (focal) seizures, which can now be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube.
• Fasenra (AstraZeneca) Expanded Indication
  • For add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.
• Dovato (ViiV) Expanded Indication
  • For the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.
• Enhertu (Daiichi Sankyo / AstraZeneca) Expanded Indication
  • For adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
• Abecma (Bristol Myers Squibb) Expanded Indication
  • Treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
• Carvykti (Janssen) Expanded Indication
  • Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.
• Zevtera (Basilea)  
  • Adults with acute bacterial skin and skin structure infections (ABSSSI) and adults with staphylococcus aureus bacteremia (SAB), a bloodstream infection that can be fatal. It also can be used on patients 3 months and older to combat community-acquired bacterial pneumonia (CABP).
• Fanapt (Vanda Pharmaceuticals) New Indication
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
• Rejoyn (Otsuka / Click Therapeutics) 
  • Treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication.
• Voydeya (AstraZeneca) 
  • As an add-on therapy to treat extravascular hemolysis in adults receiving ravulizumab or eculizumab for paroxysmal nocturnal hemoglobinuria (PNH).

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