HRP20230738T1 - Depo sustavi koji sadrže glatiramer acetat - Google Patents

Depo sustavi koji sadrže glatiramer acetat Download PDF

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Publication number
HRP20230738T1
HRP20230738T1 HRP20230738TT HRP20230738T HRP20230738T1 HR P20230738 T1 HRP20230738 T1 HR P20230738T1 HR P20230738T T HRP20230738T T HR P20230738TT HR P20230738 T HRP20230738 T HR P20230738T HR P20230738 T1 HRP20230738 T1 HR P20230738T1
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Croatia
Prior art keywords
depot formulation
lesions
rrms
use according
pronounced
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HRP20230738TT
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English (en)
Inventor
Ehud Marom
Nadav BLEICH KIMELMAN
Uri DANON
Shai Rubnov
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Mapi Pharma Ltd
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Publication of HRP20230738T1 publication Critical patent/HRP20230738T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/02Peptides of undefined number of amino acids; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/593Polyesters, e.g. PLGA or polylactide-co-glycolide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Epoxy Resins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Epoxy Compounds (AREA)
  • Chemical Vapour Deposition (AREA)

Claims (12)

1. Depo formulacija koja sadrži dozu od 40 mg glatiramer acetata (GA) za (i) ublažavanje barem jednog simptoma relapsno-remitirajuće multiple skleroze (RRMS) u osoba s RRMS-om ili osoba koje su doživjele prvu kliničku epizodu i u kojih je utvrđen visok rizik od razvoja klinički jasne multiple skleroze, pri čemu se simptom odabire iz skupine koja uključuje učestalost relapsa, broj izraženijih lezija ili broj novih lezija prema MR snimkama mozga i bolesnikov rezultat prema proširenoj ljestvici statusa onesposobljenosti (engl. Expanded Disability Status Scale, EDSS); ili (ii) postizanje koncepta NEDA bez znakova aktivnosti bolesti (engl. No Evidence of Disease Activity) u osoba s RRMS-om, pri čemu NEDA podrazumijeva izostanak sljedećeg: relapsa, 12-tjedne potvrđene progresije onesposobljenosti (engl. Confirmed Disability Progression, CDP), novih/rastućih T2 lezija i T1 lezija izraženijih primjenom gadolinija u bolesnika, pri čemu je depo formulaciju potrebno primijeniti u režimu jedne intramuskularne injekcije svakih 2 do 6 tjedana.
2. Depo formulacija za uporabu prema zahtjevu 1 koja se primjenjuje jednom svaka 4 tjedna.
3. Depo formulacija za uporabu prema zahtjevu 2 koja se primjenjuje jednom svaka 4 tjedna u razdoblju od jedne godine.
4. Depo formulacija za uporabu prema zahtjevu 1 ili 2, pri čemu ublažavanje simptoma uključuje: smanjenje učestalosti relapsa; ili smanjenje broja ili veličine izraženijih lezija ili broja novih lezija u mozgu, pri čemu je poželjno da ublažavanje simptoma uključuje smanjenje broja ili veličine lezija izraženijih primjenom gadolinija, smanjenje broja ili veličine izraženijih lezija na T1-ponderiranim snimkama ili smanjenje broja novih lezija na T2-ponderiranim snimkama bolesnika; ili smanjenje bolesnikova rezultata prema ljestvici EDSS.
5. Depo formulacija za uporabu prema zahtjevu 1, pri čemu je bolesnik primao potkožne injekcije od 20 mg GA-a jednom dnevno ili potkožne injekcije od 40 mg GA-a tri puta tjedno prije početka režima.
6. Depo formulacija za uporabu prema bilo kojem od prethodnih zahtjeva, koja nadalje sadrži farmaceutski prihvatljiv biorazgradivi nositelj odabran iz skupine koju čine kopolimer mliječne i glikolne kiseline (PLGA), polilaktična kiselina (PLA), poliglikolna kiselina (PGA) i bilo koja njihova kombinacija, pri čemu je poželjno da je biorazgradivi nositelj PLGA.
7. Depo formulacija za uporabu prema bilo kojem od prethodnih zahtjeva, koja je u obliku mikročestica pripremljenih dvostrukim postupkom emulzije „voda u ulju u vodi” (V-U-V).
8. Depo formulacija za uporabu prema bilo kojem od prethodnih zahtjeva, koja sadrži od 20 % do 30 % krute tvari.
9. Depo formulacija za uporabu prema bilo kojem od zahtjeva 6 do 8, pri čemu je težinski omjer između GA-a i farmaceutski prihvatljivog biorazgradivog nositelja između 1 : 1 i 1 : 100, pri čemu je poželjno da težinski omjer između GA-a i farmaceutski prihvatljivog biorazgradivog nositelja iznosi između 1 : 5 i 1 : 25.
10. Depo formulacija za uporabu prema bilo kojem od prethodnih zahtjeva, koja oslobađa oko 80 % glatiramera unutar 22 dana u otopinu PBS na 37 °C uz kontinuirano miješanje, ili koja oslobađa oko 20 % glatiramera unutar 5 dana u otopinu PBS na 37 °C uz kontinuirano miješanje.
11. Depo formulacija koja sadrži dozu od 40 mg glatiramer acetata (GA) za povećanje podnošljivosti lijeka GA u osoba s relapsno-remitirajućom multiplom sklerozom (RRMS), pri čemu se depo formulacija treba primijeniti u režimu od jedne intramuskularne injekcije svakih 2 do 6 tjedana, pri čemu metoda sadrži smanjenje učestalosti potkožnih injekcija s potkožnih injekcija u dozi od 20 mg GA-a primijenjenih jednom dnevno ili potkožnih injekcija u dozi od 40 mg GA-a tri puta tjedno, uz najmanje jedan dan između svake injekcije, na režim jedne intramuskularne injekcije depo formulacije u dozi od 40 mg GA-a svakih 2 do 6 tjedana, kako bi se time povećala podnošljivost bolesnika na lijek GA.
12. Komplet koji sadrži prvi spremnik koji sadrži lijek GA kapsuliran kopolimerom mliječne i glikolne kiseline (PLGA) i drugi odvojeni spremnik koji sadrži farmaceutski prihvatljiv razrjeđivač za injekciju, pri čemu komplet sadrži 40 mg GA-a i vodu za injekciju, ili pri čemu se miješanjem sadržaja prvog spremnika i drugog spremnika dobiva 40 mg GA-a po 2 ml razrjeđivača, pri čemu je komplet namijenjen za (i) ublažavanje barem jednog simptoma relapsno-remitirajuće multiple skleroze (RRMS) u osoba s RRMS-om ili osoba koje su doživjele prvu kliničku epizodu i u kojih je utvrđen visok rizik od razvoja klinički jasne multiple skleroze, pri čemu se simptom odabire iz skupine koja uključuje učestalost relapsa, broj izraženijih lezija ili broj novih lezija prema MR snimkama mozga i bolesnikov rezultat prema proširenoj ljestvici statusa onesposobljenosti (engl. Expanded Disability Status Scale, EDSS); ili (ii) postizanje koncepta NEDA bez znakova aktivnosti bolesti (engl. No Evidence of Disease Activity) u osoba s RRMS-om, pri čemu NEDA podrazumijeva izostanak sljedećeg: relapsa, 12-tjedne potvrđene progresije onesposobljenosti (engl. Confirmed Disability Progression, CDP), novih/rastućih T2 lezija i T1 lezija izraženijih primjenom gadolinija u bolesnika; ili (iii) povećanje podnošljivosti lijeka GA u bolesnika s relapsno-remitirajućom multiplom sklerozom (RRMS), metoda koja sadrži jednu intramuskularnu injekciju depo formulacije koja sadrži dozu od 40 mg glatiramer acetata (GA) svakih 2 do 6 tjedana.
HRP20230738TT 2016-08-31 2017-08-09 Depo sustavi koji sadrže glatiramer acetat HRP20230738T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662381598P 2016-08-31 2016-08-31
EP17845658.8A EP3506921B1 (en) 2016-08-31 2017-08-09 Depot systems comprising glatiramer acetate
PCT/IL2017/050882 WO2018042415A1 (en) 2016-08-31 2017-08-09 Depot systems comprising glatiramer acetate

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HRP20230738T1 true HRP20230738T1 (hr) 2023-10-27

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US (1) US20210283209A1 (hr)
EP (2) EP4252849A3 (hr)
JP (1) JP7193448B2 (hr)
CN (1) CN109982712A (hr)
AU (1) AU2017319728A1 (hr)
BR (1) BR112019003594A2 (hr)
CA (1) CA3035147A1 (hr)
DK (1) DK3506921T3 (hr)
ES (1) ES2952044T3 (hr)
FI (1) FI3506921T3 (hr)
HR (1) HRP20230738T1 (hr)
HU (1) HUE062393T2 (hr)
IL (2) IL301455B2 (hr)
LT (1) LT3506921T (hr)
MX (1) MX2019002284A (hr)
PL (1) PL3506921T3 (hr)
PT (1) PT3506921T (hr)
RS (1) RS64445B1 (hr)
SI (1) SI3506921T1 (hr)
WO (1) WO2018042415A1 (hr)

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BR112019003131A2 (pt) 2016-08-28 2019-05-21 Mapi Pharma Ltd. processo para preparar micropartículas contendo acetato de glatirâmero
MX2019010174A (es) 2017-03-26 2019-10-15 Mapi Pharma Ltd Sistemas de deposito de glatiramer para el tratamiento de formas progresivas de esclerosis multiple.
US11865213B2 (en) 2021-07-05 2024-01-09 Mapi Pharma Ltd. Semaglutide depot systems and use thereof
WO2023170493A1 (en) * 2022-03-07 2023-09-14 Hadidi Naghmeh Drug delivery using a parenteral pharmaceutical composition
WO2023175598A1 (en) * 2022-03-17 2023-09-21 Mapi Pharma Ltd. Depot systems comprising cariprazine or salts thereof

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US3773919A (en) 1969-10-23 1973-11-20 Du Pont Polylactide-drug mixtures
US5800808A (en) 1994-05-24 1998-09-01 Veda Research And Development Co., Ltd. Copolymer-1 improvements in compositions of copolymers
US6214791B1 (en) 1997-01-10 2001-04-10 Yeda Research And Development Co. Ltd. Treatment of multiple sclerosis through ingestion or inhalation of copolymer-1
US8871241B2 (en) 2002-05-07 2014-10-28 Psivida Us, Inc. Injectable sustained release delivery devices
RS52885B (en) 2009-08-20 2014-02-28 Yeda Research And Development Co. Ltd. LOW-FREQUENCY GLATIRAMER ACETATOM THERAPY
JP5916622B2 (ja) 2010-01-04 2016-05-11 マピ ファーマ リミテッド グラチラマーまたはその薬理学的に許容される塩を含むデポーシステム
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PL2529757T3 (pl) * 2011-05-31 2014-04-30 Farm Rovi Lab Sa Formulacja implantu zawierającego paliperydon
CN103169670B (zh) * 2013-03-22 2016-07-06 深圳翰宇药业股份有限公司 一种醋酸格拉替雷微球及其制备方法
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BR112019003131A2 (pt) * 2016-08-28 2019-05-21 Mapi Pharma Ltd. processo para preparar micropartículas contendo acetato de glatirâmero

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Publication number Publication date
EP4252849A2 (en) 2023-10-04
DK3506921T3 (da) 2023-07-31
CN109982712A (zh) 2019-07-05
SI3506921T1 (sl) 2023-10-30
EP3506921A4 (en) 2020-05-06
BR112019003594A2 (pt) 2019-05-21
EP3506921A1 (en) 2019-07-10
IL264914B1 (en) 2023-04-01
EP4252849A3 (en) 2023-11-01
JP2019530648A (ja) 2019-10-24
LT3506921T (lt) 2023-08-10
IL264914A (hr) 2019-04-30
IL301455A (en) 2023-05-01
MX2019002284A (es) 2019-09-04
FI3506921T3 (fi) 2023-07-21
HUE062393T2 (hu) 2023-11-28
CA3035147A1 (en) 2018-03-08
IL301455B1 (en) 2023-12-01
US20210283209A1 (en) 2021-09-16
RS64445B1 (sr) 2023-09-29
IL264914B2 (en) 2023-08-01
ES2952044T3 (es) 2023-10-26
JP7193448B2 (ja) 2022-12-20
EP3506921B1 (en) 2023-05-17
IL301455B2 (en) 2024-04-01
WO2018042415A1 (en) 2018-03-08
PT3506921T (pt) 2023-08-07
PL3506921T3 (pl) 2023-08-21
AU2017319728A1 (en) 2019-02-07

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