Guideline Med Alerts & FDA Approvals - September 2024

Otulfi (Fresenius Kabi) Biosimilar to Stelara
- For the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
Flyrcado (GE HealthCare)
- Positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD).
Dupixent (Sanofi / Regeneron) New Indication
- As an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
Cobenfy (Bristol Myers Squibb)
- For oral use for the treatment of schizophrenia in adults.
Tagrisso (AstraZeneca) New Indication
- For adult patients with locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR (epidermal growth factor receptor) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Aqneursa (IntraBio)
- For the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.
Bimzelx (UCB Pharma) New Indication
- For the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS).
Sarclisa (Sanofi) Expanded Indication
- To include treatment with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma (MM) ineligible for autologous stem cell transplant.
FluMist (AstraZeneca)Now OTC
- Now for use at home, for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age.
Miplyffa (Zevra Therapeutics)
- For use in combination with miglustat for the treatment of neurological manifestations of NPC in adults and pediatric patients 2 years of age and older.
Rybrevant (Janssen) Expanded Indication
- In combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
Fasenra (AstraZeneca) New Indication
- For the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA).
Keytruda (Merck) New Indication
- In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
Kisqali (Novartis) Expanded Indication
- In combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.
Ebglyss (Eli Lilly)
- For the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.
Ocrevus Zunovo (Genentech)New Formulation
- For the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Tecentriq Hybreza (Genentech)New Formulation
- Multiple cancer indications – same ones as IV Tecentriq.
Tremfya (Janssen)New Indication
- For the treatment of adults with moderately to severely active ulcerative colitis (UC).
Boruzu (Shilpa)New Formulation
- Ready-to-use injection for multiple myeloma and mantle cell lymphoma.

Guideline Central Blog

Guideline Med Alerts & FDA Approvals – September 2024