Pharmaceutical products and stable liquid compositions of IL-17 antibodies

{
  "publication_number": "US12599664B2",
  "country": "US",
  "kind": "B2",
  "title": "Pharmaceutical products and stable liquid compositions of IL-17 antibodies",
  "abstract": "The disclosure is directed to pharmaceutical products and stable liquid compositions of IL-17 antibodies and antigen-binding fragments thereof, e.g., AIN457 (secukinumab), and processes of making these pharmaceutical products and compositions. The disclosure is also directed to the use of these pharmaceutical products and liquid compositions (e.g., as part of a kit having instructions for use) for the treatment of various IL-17-mediated disorders (e.g., autoimmune disorders, such as psoriasis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis).",
  "claims": [
    "1. wherein the buffer is selected from the group consisting of gluconate, histidine, citrate, phosphate, succinate, acetate, Tris, glycine, arginine, and a combination thereof; ii. comprises a non-ionic stabilizer at a concentration of about 175 mM to about 350 mM; wherein the non-ionic stabilizer is mannitol, trehalose, raffinose, maltose, sorbitol, or a combination thereof; iii. comprises about 25 mg/mL to about 150 mg/mL secukinumab; and iv. comprises from at least 2.5 mM methionine to about 67 mM methionine. 40. The process of claim 39, wherein the liquid composition comprises an amino acid stabilizer. 41. The process of claim 40, wherein the amino acid stabilizer is glycine and/or arginine. 42. The process of claim 39, wherein the liquid composition comprises a surfactant. 43. The process of claim 42, wherein the surfactant is a polysorbate, a poloxamer, or a combination thereof. 44. The process of claim 43, wherein the surfactant is a polyoxyethylene sorbitan fatty acid ester. 45. The process of claim 43, wherein the surfactant is polysorbate 20 or polysorbate 80. 46. The process of claim 45 wherein the surfactant is polysorbate 80. 47. The process of claim 46, wherein the surfactant is polysorbate 80 at a concentration of about 0.01% to about 0.04% (w/v)."
  ],
  "description_excerpt": "The disclosure is directed to pharmaceutical products comprising stable liquid pharmaceutical compositions of IL-17 antibodies and antigen-binding fragments thereof, e.g., AIN457 (secukinumab), and processes of making such pharmaceutical products and liquid pharmaceutical compositions.\n\nIL-17A is the central lymphokine of a newly defined subset of inflammatory T cells, the Th17 cells, which are pivotal in several autoimmune and inflammatory processes. IL-17A neutralization is expected to treat the underlying pathophysiology of immune mediated disease, and as a consequence provide relief of symptoms. Secukinumab (AIN457) is a high-affinity fully human monoclonal anti-human antibody that inhibits IL-17A activity, which has emerged as a potential treatment for patients with various autoimmune diseases, e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, diabetes, asthma, chronic plaque-type psoriasis, and multiple sclerosis. Several Phase II and III studies have shown that secukinumab is superior to placebo in achievement of PASI 75 in treating chronic plaque-type psoriasis (e.g., secukinumab 3×150 mg and 3×75 mg were both superior to placebo in achievement of PASI 75 at Week 12 (81.5% and 57.1%, respectively, vs. 9.1%) in study CAIN457A2220. Secukinumab is currently used in global Phase III studies for the treatment of chronic plaque-type psoriasis, and has again shown superiority over placebo, and newly also over etanercept.",
  "cpc": [
    "A61K 39/39591",
    "C07K 16/244",
    "C07K 2317/21",
    "H04L 5/0016",
    "H04L 5/0023",
    "H04L 5/0051"
  ],
  "ipc": [
    "A61K 39/395",
    "C07K 16/24",
    "H04L 5/00"
  ],
  "assignees": [
    "Novartis AG"
  ],
  "inventors": [
    "Susanne JOERG",
    "Kathrin SERNO-SCHERSCH"
  ],
  "filing_date": "2023-10-04",
  "publication_date": "2026-04-14",
  "grant_date": "2026-04-14",
  "priority_date": "2014-12-22",
  "application_number": "US-202318481213-A",
  "family_id": "55135471",
  "cited_by_count": 0,
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