HRP20240282T1 - Upotreba kladribina za liječenje autoimune neuromuskularne bolesti - Google Patents
Upotreba kladribina za liječenje autoimune neuromuskularne bolesti Download PDFInfo
- Publication number
- HRP20240282T1 HRP20240282T1 HRP20240282TT HRP20240282T HRP20240282T1 HR P20240282 T1 HRP20240282 T1 HR P20240282T1 HR P20240282T T HRP20240282T T HR P20240282TT HR P20240282 T HRP20240282 T HR P20240282T HR P20240282 T1 HRP20240282 T1 HR P20240282T1
- Authority
- HR
- Croatia
- Prior art keywords
- cladribine
- use according
- preparation
- unit dose
- composition
- Prior art date
Links
- PTOAARAWEBMLNO-KVQBGUIXSA-N Cladribine Chemical compound C1=NC=2C(N)=NC(Cl)=NC=2N1[C@H]1C[C@H](O)[C@@H](CO)O1 PTOAARAWEBMLNO-KVQBGUIXSA-N 0.000 title claims 13
- 229960002436 cladribine Drugs 0.000 title claims 11
- 230000001363 autoimmune Effects 0.000 title 1
- 208000018360 neuromuscular disease Diseases 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 5
- 230000001186 cumulative effect Effects 0.000 claims 4
- 210000001744 T-lymphocyte Anatomy 0.000 claims 2
- 230000037396 body weight Effects 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000012669 liquid formulation Substances 0.000 claims 2
- 206010028417 myasthenia gravis Diseases 0.000 claims 2
- 238000002203 pretreatment Methods 0.000 claims 2
- 239000007963 capsule composition Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000007916 tablet composition Substances 0.000 claims 1
Classifications
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/04—Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Saccharide Compounds (AREA)
Claims (12)
1. 2-klor-2'-deoksiadenozin, poznat kao kladribin, ili njegova farmaceutski prihvatljiva sol, za upotrebu u liječenju ili ublažavanju miastenije gravis.
2. Farmaceutski pripravak naznačen time što sadrži 2-klor-2'-deoksiadenozin, poznat kao kladribin i jednu ili više farmaceutski prihvatljivih pomoćnih tvari za upotrebu u liječenju ili ublažavanju miastenije gravis.
3. Pripravak za upotrebu prema zahtjevu 2 u obliku jedinične doze, koji sadrži 1-20 mg po jediničnoj dozi.
4. Pripravak za upotrebu prema zahtjevu 2 u obliku jedinične doze, koji sadrži 2.5-15 mg po jediničnoj dozi.
5. Pripravak za upotrebu prema zahtjevu 2 u obliku jedinične doze, koji sadrži 8-12 mg po jediničnoj dozi
6. Pripravak za upotrebu prema bilo kojem od zahtjeva 2-5, koji je tableta, kapsula ili tekuća formulacija.
7. Pripravak za upotrebu prema bilo kojem od zahtjeva 2-5, predstavljen u sterilnoj tekućoj formulaciji prikladnoj za injekciju.
8. Pripravak za upotrebu prema bilo kojem od zahtjeva 2-7, za dnevnu primjenu kao jedna doza.
9. Kladribin ili pripravak za upotrebu prema bilo kojem od zahtjeva 2-8, za primjenu u učinkovitoj količini određenoj kao učinkovita kumulativna količina kladribina primijenjena između 1 i 20 dana doziranja, raspoređena tijekom između 1 i 16 tjedana, koja rezultira sa smanjenjem CD3+ T stanica od između 30 i 80%, u odnosu na razine prije liječenja.
10. Kladribin ili pripravak za upotrebu prema zahtjevu 9, za primjenu u učinkovitoj količini određenoj kao učinkovita kumulativna količina kladribina primijenjena između 1 i 20 dana doziranja, raspoređena tijekom između 5 i 10 tjedana, koja rezultira sa smanjenjem CD3+ T stanica od između 40 i 60% u odnosu na razine prije liječenja.
11. Kladribin ili pripravak prema bilo kojem prethodnom zahtjevu za upotrebu u učinkovitoj kumulativnoj dozi ili količini od 0,1 do 6 mg kladribina po kilogramu tjelesne težine pacijenta (mg/kg) u lijeku uzima se tijekom razdoblja od jedne do dvije godine.
12. Kladribin ili pripravak prema bilo kojem od zahtjeva 1-13 za upotrebu u učinkovitoj kumulativnoj dozi ili količini od 0,2 do 2,5 mg/kg kladribina tjelesne težine pacijenta (mg/kg) u lijeku se uzima tijekom razdoblja od jedne do dvije godine.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB1711800.1A GB2564717A (en) | 2017-07-21 | 2017-07-21 | Use of cladribine for treating autoimmune neuromuscular disease |
| EP18739593.4A EP3654989B1 (en) | 2017-07-21 | 2018-06-28 | Use of cladribine for treating autoimmune neuromuscular disease |
| PCT/GB2018/051801 WO2019016505A1 (en) | 2017-07-21 | 2018-06-28 | USE OF CLADRIBINE FOR THE TREATMENT OF AUTOIMMUNE NEUROMUSCULAR DISEASE |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240282T1 true HRP20240282T1 (hr) | 2024-05-10 |
Family
ID=59771723
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240282TT HRP20240282T1 (hr) | 2017-07-21 | 2018-06-28 | Upotreba kladribina za liječenje autoimune neuromuskularne bolesti |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US20200163986A1 (hr) |
| EP (2) | EP4292663A3 (hr) |
| JP (1) | JP7186214B2 (hr) |
| CA (1) | CA3095893A1 (hr) |
| DK (1) | DK3654989T3 (hr) |
| ES (1) | ES2974423T3 (hr) |
| FI (1) | FI3654989T3 (hr) |
| GB (1) | GB2564717A (hr) |
| HR (1) | HRP20240282T1 (hr) |
| HU (1) | HUE066238T2 (hr) |
| LT (1) | LT3654989T (hr) |
| PL (1) | PL3654989T3 (hr) |
| PT (1) | PT3654989T (hr) |
| RS (1) | RS65246B1 (hr) |
| SI (1) | SI3654989T1 (hr) |
| WO (1) | WO2019016505A1 (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2601786A (en) * | 2020-12-10 | 2022-06-15 | Chord Therapeutics S A R L | Use of cladribine for treating immune brain disease |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA1269659A (en) | 1984-08-06 | 1990-05-29 | Brigham Young University | Method for the production of 2'-deoxyadenosine compounds |
| US5310732A (en) | 1986-02-03 | 1994-05-10 | The Scripps Research Institute | 2-halo-2'-deoxyadenosines in the treatment of rheumatoid arthritis |
| US5208327A (en) | 1991-12-18 | 1993-05-04 | Ortho Pharmaceutical Corporation | Intermediates useful in a synthesis of 2-chloro-2'-deoxyadenosine |
| EP1200102A1 (en) * | 1999-07-22 | 2002-05-02 | Supergen, Inc. | Methods for treating autoimmune diseases |
| CA2503150A1 (en) * | 2002-10-31 | 2004-05-21 | Supergen, Inc. | Pharmaceutical formulations targeting specific regions of the gastrointestinal tract |
| AU2003291049A1 (en) * | 2002-11-22 | 2004-06-18 | Transclick, Inc. | System and method for speech translation using remote devices |
| MXPA05010330A (es) | 2003-03-28 | 2006-05-31 | Ivax Corp | Formulaciones de cladribina para el mejor suministro oral y a traves de la mucosa. |
| EP1827461B1 (en) * | 2004-12-22 | 2012-02-29 | Merck Serono SA | Cladribine regimen for treating multiple sclerosis |
| AU2007253254B2 (en) * | 2006-05-24 | 2013-01-17 | Merck Serono Sa | Cladribine regimen for treating multiple sclerosis |
-
2017
- 2017-07-21 GB GB1711800.1A patent/GB2564717A/en not_active Withdrawn
-
2018
- 2018-06-28 PT PT187395934T patent/PT3654989T/pt unknown
- 2018-06-28 SI SI201831074T patent/SI3654989T1/sl unknown
- 2018-06-28 LT LTEPPCT/GB2018/051801T patent/LT3654989T/lt unknown
- 2018-06-28 HU HUE18739593A patent/HUE066238T2/hu unknown
- 2018-06-28 EP EP23205297.7A patent/EP4292663A3/en active Pending
- 2018-06-28 CA CA3095893A patent/CA3095893A1/en active Pending
- 2018-06-28 WO PCT/GB2018/051801 patent/WO2019016505A1/en active Application Filing
- 2018-06-28 EP EP18739593.4A patent/EP3654989B1/en active Active
- 2018-06-28 US US16/632,245 patent/US20200163986A1/en active Pending
- 2018-06-28 PL PL18739593.4T patent/PL3654989T3/pl unknown
- 2018-06-28 DK DK18739593.4T patent/DK3654989T3/da active
- 2018-06-28 HR HRP20240282TT patent/HRP20240282T1/hr unknown
- 2018-06-28 JP JP2020502477A patent/JP7186214B2/ja active Active
- 2018-06-28 RS RS20240253A patent/RS65246B1/sr unknown
- 2018-06-28 FI FIEP18739593.4T patent/FI3654989T3/fi active
- 2018-06-28 ES ES18739593T patent/ES2974423T3/es active Active
Also Published As
| Publication number | Publication date |
|---|---|
| EP3654989A1 (en) | 2020-05-27 |
| EP3654989B1 (en) | 2024-01-03 |
| PT3654989T (pt) | 2024-02-28 |
| US20200163986A1 (en) | 2020-05-28 |
| ES2974423T3 (es) | 2024-06-27 |
| EP4292663A3 (en) | 2024-03-20 |
| PL3654989T3 (pl) | 2024-05-20 |
| FI3654989T3 (fi) | 2024-03-21 |
| RS65246B1 (sr) | 2024-03-29 |
| HUE066238T2 (hu) | 2024-07-28 |
| GB201711800D0 (en) | 2017-09-06 |
| GB2564717A (en) | 2019-01-23 |
| DK3654989T3 (da) | 2024-02-26 |
| EP4292663A2 (en) | 2023-12-20 |
| JP7186214B2 (ja) | 2022-12-08 |
| WO2019016505A1 (en) | 2019-01-24 |
| JP2020527156A (ja) | 2020-09-03 |
| LT3654989T (lt) | 2024-03-25 |
| SI3654989T1 (sl) | 2024-06-28 |
| CA3095893A1 (en) | 2019-01-24 |
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