MX375672B - Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9. - Google Patents

Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9.

Info

Publication number
MX375672B
MX375672B MX2017015018A MX2017015018A MX375672B MX 375672 B MX375672 B MX 375672B MX 2017015018 A MX2017015018 A MX 2017015018A MX 2017015018 A MX2017015018 A MX 2017015018A MX 375672 B MX375672 B MX 375672B
Authority
MX
Mexico
Prior art keywords
formulations containing
containing anti
pcsk9
antibody
pcsk9 antibodies
Prior art date
Application number
MX2017015018A
Other languages
English (en)
Inventor
Daniel Dix
Scott Walsh
Original Assignee
Regeneron Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46889415&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX375672(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of MX375672B publication Critical patent/MX375672B/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La presente invención proporciona formulaciones farmacéuticas que comprenden un anticuerpo humano que se une específicamente a la proproteína humana convertasa subtilisina/kexina tipo 9 (PCSK9). Las formulaciones pueden contener, además de un anticuerpo anti-PCSK9, al menos un aminoácido, al menos un azúcar o al menos un tensioactivo no iónico. Las formulaciones farmacéuticas de la presente invención muestran un grado sustancial de estabilidad del anticuerpo tras su almacenamiento durante varios meses.
MX2017015018A 2011-07-28 2012-07-27 Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9. MX375672B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161512666P 2011-07-28 2011-07-28
PCT/US2012/048574 WO2013016648A2 (en) 2011-07-28 2012-07-27 Stabilized formulations containing anti-pcsk9 antibodies

Publications (1)

Publication Number Publication Date
MX375672B true MX375672B (es) 2025-03-06

Family

ID=46889415

Family Applications (3)

Application Number Title Priority Date Filing Date
MX2014000771A MX352529B (es) 2011-07-28 2012-07-27 Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9.
MX2017015018A MX375672B (es) 2011-07-28 2012-07-27 Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9.
MX2020010470A MX2020010470A (es) 2011-07-28 2014-01-20 Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2014000771A MX352529B (es) 2011-07-28 2012-07-27 Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2020010470A MX2020010470A (es) 2011-07-28 2014-01-20 Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9.

Country Status (20)

Country Link
US (7) US8795669B2 (es)
EP (2) EP2736529A2 (es)
JP (3) JP6045583B2 (es)
KR (1) KR102001818B1 (es)
CN (2) CN103717237A (es)
AR (1) AR087305A1 (es)
AU (2) AU2012286663B2 (es)
BR (1) BR112014001712B1 (es)
CA (1) CA2841588C (es)
CL (1) CL2014000183A1 (es)
CO (1) CO6862108A2 (es)
EA (3) EA028227B1 (es)
IL (1) IL230282B (es)
MA (1) MA35355B1 (es)
MX (3) MX352529B (es)
MY (1) MY165156A (es)
PH (1) PH12013502602A1 (es)
TW (1) TWI586366B (es)
UY (1) UY34228A (es)
WO (1) WO2013016648A2 (es)

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EP3762026A1 (en) 2018-03-06 2021-01-13 Sanofi Biotechnology Use of pcsk9 inhibitor for reducing cardiovascular risk

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