ES2916649T1 - Composiciones y usos para el tratamiento de la esclerosis múltiple - Google Patents

Composiciones y usos para el tratamiento de la esclerosis múltiple Download PDF

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Publication number
ES2916649T1
ES2916649T1 ES13169139T ES13169139T ES2916649T1 ES 2916649 T1 ES2916649 T1 ES 2916649T1 ES 13169139 T ES13169139 T ES 13169139T ES 13169139 T ES13169139 T ES 13169139T ES 2916649 T1 ES2916649 T1 ES 2916649T1
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Prior art keywords
fumarate
administered
monomethyl
dimethyl
dimethyl fumarate
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ES13169139T
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ES2916649T3 (es
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Matvey Lukashev
Gilmore O'neill
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Biogen MA Inc
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Biogen MA Inc
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/502—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4704—2-Quinolinones, e.g. carbostyril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/217—IFN-gamma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/502—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects
    • G01N33/5041—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing non-proliferative effects involving analysis of members of signalling pathways
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/902—Oxidoreductases (1.)
    • G01N2333/90209—Oxidoreductases (1.) acting on NADH or NADPH (1.6), e.g. those with a heme protein as acceptor (1.6.2) (general), Cytochrome-b5 reductase (1.6.2.2) or NADPH-cytochrome P450 reductase (1.6.2.4)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/28—Neurological disorders
    • G01N2800/285—Demyelinating diseases; Multipel sclerosis

Abstract

Una composición farmacéutica para usarse en el tratamiento de la esclerosis múltiple, comprendiendo la composición: (a) fumarato de dimetilo y/o fumarato de monometilo, y (b) uno o más excipientes farmacéuticamente aceptables, donde la composición se va a administrar por vía oral a un sujeto que necesita tratamiento para la esclerosis múltiple, y donde la dosis de fumarato de dimetilo o fumarato de monometiloque se va a administrar es de aproximadamente 480 mg a aproximadamente 720 mg por día.

Claims (21)

REIVINDICACIONES
1. Una composición farmacéutica para usarse en el tratamiento de la esclerosis múltiple, comprendiendo la composición: (a) fumarato de dimetilo y/o fumarato de monometilo, y
(b) uno o más excipientes farmacéuticamente aceptables,
donde la composición se va a administrar por vía oral a un sujeto que necesita tratamiento para la esclerosis múltiple, y donde la dosis de fumarato de dimetilo o fumarato de monometiloque se va a administrar es de aproximadamente 480 mg a aproximadamente 720 mg por día.
2. La composición farmacéutica para usarse como en la reivindicación 1, donde la composición comprende fumarato de dimetilo y uno o más excipientes farmacéuticamente aceptables.
3. La composición farmacéutica para usarse como en la reivindicación 1, donde la composición comprende fumarato de monometiloy uno o más excipientes farmacéuticamente aceptables.
4. La composición farmacéutica para usarse como en una cualquiera de las reivindicaciones 1 a 3, donde la dosis de fumarato de dimetilo o fumarato de monometiloque se va a administrar es de aproximadamente 480 mg por día.
5. La composición farmacéutica para usarse como en una cualquiera de las reivindicaciones 1 a 4, donde la composición se va a administrar en forma de tableta, suspensión o cápsula.
6. La composición farmacéutica para usarse como en una cualquiera de las reivindicaciones 1 a 5, donde el fumarato de dimetilo y/o el fumarato de monometilo se va a administrar en administraciones separadas de 2, 3, 4 o 6 dosis iguales.
7. La composición farmacéutica para usarse como en la reivindicación 6, donde la dosis de fumarato de dimetilo o fumarato de monometilo se va a administrar en administraciones separadas de 2 dosis iguales.
8. La composición farmacéutica para usarse como en la reivindicación 6, donde la dosis de fumarato de dimetilo o fumarato de monometilo se va a administrar en administraciones separadas de 3 dosis iguales.
9. La composición farmacéutica para usarse como en una cualquiera de las reivindicaciones 1 a 8, donde la composición se va a administrar al sujeto durante 5, 10, 12, 20, 40, 52, 100 o 200 semanas o más.
10. La composición farmacéutica para usarse como en una cualquiera de las reivindicaciones 1 a 9, donde la composición se va a administrar al sujeto durante al menos 12 semanas.
11. Fumarato de dimetilo o fumarato de monometilo para usarse en el tratamiento de la esclerosis múltiple, donde el fumarato de dimetilo o el fumarato de monometilo se van a administrar por vía oral a un sujeto que necesita tratamiento para la esclerosis múltiple a una dosis de aproximadamente 480 mg a aproximadamente 720 mg por día.
12. Fumarato de dimetilo o fumarato de monometilo para usarse como en la reivindicación 11, donde el fumarato de dimetilo o el fumarato de monometilo es el único compuesto neuroprotector que se va a administrar.
13. Fumarato de dimetilo para usarse como en la reivindicación 12, donde el fumarato de dimetilo es el único compuesto neuroprotector que se va a administrar.
14. Fumarato de monometilo para usarse como en la reivindicación 12, donde el fumarato de monometilo es el único compuesto neuroprotector que se va a administrar.
15. El fumarato de dimetilo o el fumarato de monometilo para usarse como en una cualquiera de las reivindicaciones 11 a 14, donde la dosis es de aproximadamente 480 mg por día.
16. El fumarato de dimetilo o el fumarato de monometilo para usarse como en una cualquiera de las reivindicaciones 11 a 15, donde el fumarato de dimetilo o el fumarato de monometilo se va a administrar en forma de comprimido, suspensión o cápsula.
17. El fumarato de dimetilo o fumarato de monometilo para usarse como en una cualquiera de las reivindicaciones 11 a 16, donde la dosis se va a administrar en administraciones separadas de 2, 3, 4 o 6 dosis iguales.
18. El fumarato de dimetilo o fumarato de monometilo para usarse como en la reivindicación 17, donde la dosis se va a administrar en administraciones separadas de 2 dosis iguales.
19. El fumarato de dimetilo o fumarato de monometilo para usarse como en la reivindicación 17, donde la dosis se va a administrar en administraciones separadas de 3 dosis iguales.
20. El fumarato de dimetilo o el fumarato de monometilo para usarse como en cualquiera de las reivindicaciones 11 a 19, donde el fumarato de dimetilo o el fumarato de monometilo se va a administrar al sujeto durante 5, 10, 12, 20, 40, 52, 100 o 200 semanas o más.
21. El fumarato de dimetilo o el fumarato de monometilo para usarse como en cualquiera de las reivindicaciones 11 a 20, donde el fumarato de dimetilo o el fumarato de monometilo se va a administrar al sujeto durante al menos 12 semanas.
ES13169139T 2007-02-08 2008-02-07 Composiciones y usos para el tratamiento de la esclerosis múltiple Active ES2916649T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US88892107P 2007-02-08 2007-02-08

Publications (2)

Publication Number Publication Date
ES2916649T1 true ES2916649T1 (es) 2022-07-04
ES2916649T3 ES2916649T3 (es) 2022-09-21

Family

ID=39682314

Family Applications (3)

Application Number Title Priority Date Filing Date
ES08725256T Active ES2424022T3 (es) 2007-02-08 2008-02-07 Composiciones y usos para tratar la esclerosis múltiple
ES13169139T Active ES2916649T3 (es) 2007-02-08 2008-02-07 Composiciones y usos para el tratamiento de la esclerosis múltiple
ES13156663T Pending ES2916604T1 (es) 2007-02-08 2008-02-07 Ensayos de detección de nrf2 y métodos y composiciones relacionados

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES08725256T Active ES2424022T3 (es) 2007-02-08 2008-02-07 Composiciones y usos para tratar la esclerosis múltiple

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES13156663T Pending ES2916604T1 (es) 2007-02-08 2008-02-07 Ensayos de detección de nrf2 y métodos y composiciones relacionados

Country Status (19)

Country Link
US (8) US20110112196A1 (es)
EP (10) EP4137819A1 (es)
CY (2) CY1114340T1 (es)
DE (2) DE13169139T1 (es)
DK (3) DK2653873T3 (es)
ES (3) ES2424022T3 (es)
FI (2) FI2629097T1 (es)
FR (2) FR14C0050I1 (es)
HK (1) HK1139204A1 (es)
HR (2) HRP20220902T3 (es)
HU (1) HUS2300001I1 (es)
LT (2) LT2653873T (es)
LU (1) LU92487I2 (es)
NO (1) NO2023001I1 (es)
PL (2) PL2653873T3 (es)
PT (2) PT2653873T (es)
RS (2) RS52922B (es)
SI (2) SI2653873T1 (es)
WO (1) WO2008097596A2 (es)

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LU92487I2 (fr) 2015-11-02
PL2653873T1 (pl) 2022-07-04
EP4137819A1 (en) 2023-02-22
LT2653873T (lt) 2022-10-10

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