The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug or device under consideration. Presented below is a comprehensive list of drugs and devices, along with the anticipated decision date.

Upcoming FDA Decisions for June 2024

  • AdCom Meeting Date: June 4, 2024
    • Midomafetamine (MDMA)
    • Lykos Therapeutics
    • Used in combination with psychological intervention (“MDMA-assisted therapy”) for adults with post-traumatic stress disorder (“PTSD”).
  • AdCom Meeting Date: June 10, 2024
    • Donanemab
    • Eli Lilly and Co.
    • A monoclonal antibody for the treatment of early symptomatic Alzheimer’s disease.
  • PDUFA Date: June 10, 2024
    • Elafibranor
    • Ibsen
    • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • PDUFA Date: June 15, 2024
    • Augtyro™ (repotrectinib)
    • Bristol Myers Squibb
    • For the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
  • PDUFA Date: June 15, 2024
    • VYVGART® (efgartigimod alfa injection)
    • Zai Lab
    • For the treatment of adult patients with generalized myasthenia gravis (gMG), who are anti-acetylcholine receptor (AChR) antibody positive.
  • PDUFA Date: June 16, 2024
    • Imetelstat
    • Geron Corporation
    • A first-in-class telomerase inhibitor, for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS).
  • PDUFA Date: June 17, 2024
    • V116
    • Merck & Co
    • An investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
  • PDUFA Date: June 21, 2024
    • KRAZATI® (adagrasib)
    • Bristol Myers Squibb
    • KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).
  • PDUFA Date: June 21, 2024
    • WAKIX® (pitolisant)
    • Harmony Biosciences
    • For the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients 6 years of age and older with narcolepsy.
  • PDUFA Date: June 21, 2024
    • KEYTRUDA® (pembrolizumab)
    • Merck & Co
    • KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma.
  • PDUFA Date: June 27, 2024
    • Dupixent®
    • Sanofi Aventis
    • As an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).
  • PDUFA Date: June 28, 2024
    • Epcoritamab-bysp
    • Genmab A/S
    • A T-cell engaging bispecific antibody administered subcutaneously, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
  • PDUFA Date: June 30, 2024
    • KRESLADI™ (marnetegragene autotemcel)
    • Rocket Pharmaceuticals
    • An investigational gene therapy that contains autologous (patient-derived) hematopoietic stem cells that have been genetically modified with a lentiviral (LV) vector to deliver a functional copy of the ITGB2 gene, which encodes for the beta-2 integrin component CD18, a key protein that facilitates leukocyte adhesion and enables their extravasation from blood vessels to fight infection.

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