{
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  "id": "maternal:beyfortus",
  "owner": "maternal",
  "kind": "product",
  "slug": "beyfortus",
  "name": "Beyfortus (nirsevimab)",
  "aliases": [],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A brand-name injection of the RSV antibody nirsevimab. FDA approved it in July 2023. The current US label covers newborns and infants in their first RSV season, and some children up to 24 months who stay at risk through a second season.",
  "summary_technical": "US BLA761328, original application approved 2023-07-17 (Drugs@FDA through openFDA); the active ingredient is nirsevimab-alip. Sponsor in openFDA: AstraZeneca AB; the label record names Sanofi Vaccines US as manufacturer. The indication on this page is the current label's (effective 2026-07-13), not the 2023 label's; later efficacy and labelling supplements are listed in openFDA and were not read. Label SPL set id 2f08fa60-f674-432d-801b-1f9514bd9b39. The recipient is the infant.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
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      "value": "2f08fa60-f674-432d-801b-1f9514bd9b39",
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      "match": "exact",
      "version": null,
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      "from_source": false
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  "navigation": {
    "maternal": {
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        "newborn",
        "infant-follow-up"
      ],
      "care-area": [
        "infant-health"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "model_or_formulation": "Nirsevimab-alip injection for intramuscular use, 50 mg and 100 mg products (openFDA Drugs@FDA product list; the label record gives the route as intramuscular).",
    "version": "As approved under BLA761328 on 2023-07-17; label text is the current label effective 2026-07-13 as served by openFDA.",
    "intended_use_snapshots": [
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      "category": "regulatory",
      "statement": "Drugs@FDA, through openFDA, lists the original application for Beyfortus (nirsevimab-alip), BLA761328, as approved on 17 July 2023. The current label, effective 13 July 2026, words the indication as the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.",
      "context": {
        "id": "maternal:ctx-fda-bla761328-us",
        "label": "Neonates, infants and children up to 24 months at risk of RSV lower respiratory tract disease (Beyfortus labelled use, United States)",
        "recipient": "child",
        "population": "Neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, as the current label words the indication.",
        "care_setting": "Prescription biologic given by injection into the muscle (openFDA marketing status in the label record).",
        "geography": "United States (FDA)",
        "life_stage_note": "Neonates, infants and children up to 24 months",
        "life_stage_terms": {
          "maternal": [
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            "infant-follow-up"
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        },
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory context)",
        "eligibility": {
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            "Neonates and infants born during or entering their first RSV season",
            "Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season"
          ],
          "exclusion": [
            "Not stated in the parts of the label that were read; see the label for contraindications and warnings"
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      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "An approval is an FDA decision about a product. It is not a recommendation to use the medicine for any person. The indication is quoted from today's label, not from the 2023 label; openFDA lists later efficacy and labelling supplements, and the 2023 indication was not read. openFDA's sponsor is AstraZeneca AB and the label record names Sanofi Vaccines US as manufacturer; the atlas does not trace that arrangement. openFDA says its data is unvalidated.",
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