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HRP20240319T1 - Pripravci i postupci za liječenje anemije - Google Patents

Pripravci i postupci za liječenje anemije Download PDF

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Publication number
HRP20240319T1
HRP20240319T1 HRP20240319TT HRP20240319T HRP20240319T1 HR P20240319 T1 HRP20240319 T1 HR P20240319T1 HR P20240319T T HRP20240319T T HR P20240319TT HR P20240319 T HRP20240319 T HR P20240319T HR P20240319 T1 HRP20240319 T1 HR P20240319T1
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HRP20240319TT
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Robert Shalwitz
Charlotte HARTMAN
Akshay BUCH
Isaiah SHALWITZ
John JANUSZ
Joseph Gardner
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Akebia Therapeutics, Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=52022903&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20240319(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Akebia Therapeutics, Inc. filed Critical Akebia Therapeutics, Inc.
Publication of HRP20240319T1 publication Critical patent/HRP20240319T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4412Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pyridine Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Claims (16)

1. Spoj za uporabu u postupku za liječenje anemije sekundarne kroničnoj bubrežnoj bolesti kod subjekta ili anemije kod subjekta s kroničnom bubrežnom bolešću, pri čemu je spoj {[5-(3-klorofenil)-3-hidroksipiridin-2-ugljik-il]amino}octena kiselina, koja ima strukturu: [image] ili njegova farmaceutski prihvatljiva sol, i pri čemu postupak uključuje oralnu primjenu spoja u dozi jednom dnevno od 100 mg do 800 mg.
2. Spoj za uporabu prema zahtjevu 1, naznačen time što je jednom dnevna doza 150 mg do 300 mg ili 300 mg do 600 mg.
3. Spoj za uporabu prema zahtjevu 1, naznačen time što je spoj pogodan za povećanje ukupnih razina eritropoetina u dnevnom obrascu.
4. Spoj za uporabu prema zahtjevu 3, naznačen time da su najniže razine eritropoetina povišene u usporedbi s najnižim razinama eritropoetina kod subjekta neposredno prije koraka primjene za najviše 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, ili 20%.
5. Spoj za uporabu prema zahtjevu 1, naznačen time što je kronična bolest bubrega stupanj 3, 4 ili 5 kronične bolesti bubrega.
6. Spoj za uporabu prema zahtjevima 1 ili 5, naznačen time što je kronična bubrežna bolest kronična bubrežna bolest prije dijalize.
7. Spoj za uporabu prema bilo kojem od zahtjeva 1-6, naznačen time što pacijent nije prethodno liječen od anemije; i/ili je pacijent otporan na liječenje rekombinantnim eritropoetinom; i/ili je pacijent prethodno liječen od anemije.
8. Spoj za uporabu prema bilo kojem od zahtjeva 1-6, naznačen time što su razine hemoglobina pacijenta a. održavaju se na razini od najmanje 9.0 g/dL i na ili ispod 13.0 g/dL; ili b. održavaju se na razini od najmanje 10.0 g/dL i na ili ispod 13.0 g/dL; ili c. održavaju se na razini od najmanje 11.0 g/dL i na ili ispod 13.0 g/dL; ili d. povećane su za najmanje 1.2 g/dL u odnosu na osnovnu razinu hemoglobina, poželjno je da se razine hemoglobina testiraju najmanje 1 dan, 2 dana, 3 dana, 4 dana, 5 dana, 6 dana, 7 dana, 8 dana, 9 dana, 10 dana, 11 dana, 12 dana, 13 dana, 14 dana, 3 tjedna, 4 tjedna, 5 tjedana, 6 tjedana, 7 tjedana, ili 8 tjedana nakon početne primjene spoja.
9. Spoj za uporabu prema bilo kojem od zahtjeva 1-8, naznačen time što postupak ne uključuje davanje dodatka željeza.
10. Spoj za uporabu prema bilo kojem od zahtjeva 1-9, naznačen time što se spoj primjenjuje jednom dnevno u isto doba dana, poželjno je da je doba dana ujutro ili rano poslijepodne.
11. Spoj za uporabu prema zahtjevu 1, naznačen time što postupak sadrži a. davanje početne dnevne doze spoja pacijentu koji ima anemiju; b. uzimanje prvog mjerenja razine hemoglobina kod pacijenta i naknadno uzimanje drugog mjerenja razine hemoglobina kod pacijenta, pri čemu i. ako je razina hemoglobina kod pacijenta pri drugom mjerenju manja od 10.0 g/dL i ako je razina hemoglobina smanjena za manje od 0.5 g/dL u odnosu na razinu pri prvom mjerenju; ili ii. ako je razina hemoglobina kod bolesnika pri drugom mjerenju manja od 10.0 g/dL i ako se razina hemoglobina promijenila do 0.4 g/dL u odnosu na razinu pri prvom mjerenju; ili iii. ako je razina hemoglobina kod pacijenta pri drugom mjerenju između 10.0 i 10.9 g/dL i ako je razina hemoglobina smanjena za manje od 0.5 g/dL u odnosu na razinu pri prvom mjerenju; ili iv. ako je razina hemoglobina kod pacijenta pri drugom mjerenju manja od 10.0 g/dL i ako je razina hemoglobina porasla za više od 1.5 g/dL u odnosu na razinu pri prvom mjerenju; ili v. ako je razina hemoglobina kod pacijenta pri drugom mjerenju između 10.0 i 10.9 g/dL i ako je razina hemoglobina porasla za više od 1.5 g/dL u odnosu na razinu pri prvom mjerenju; ili vi. ako je razina hemoglobina kod pacijenta pri drugom mjerenju između 11.0 i 12.2 g/dL i ako je razina hemoglobina porasla za između 1.0 i 1.4 g/dL u odnosu na razinu pri prvom mjerenju; ili vii. ako je razina hemoglobina u pacijenta pri drugom mjerenju između 12.3 i 12.9 g/dL i razina hemoglobina se smanjila do 0.4 g/dL ili povećala do 0.4 g/dL u odnosu s prvim mjerenjem; ili viii. ako je razina hemoglobina kod pacijenta pri drugom mjerenju između 12.3 i 12.9 g/dL i ako je razina hemoglobina porasla za 0.5 do 0.9 g/dL u odnosu na razinu pri prvom mjerenju; ili ix. ako je razina hemoglobina kod pacijenta pri drugom mjerenju između 11.0 i 12.2 g/dL i ako je razina hemoglobina porasla za više od 1.5 g/dL u odnosu na razinu pri prvom mjerenju; ili x. ako je razina hemoglobina kod pacijenta pri drugom mjerenju između 12.3 i 12.9 g/dL i ako je razina hemoglobina porasla za između 1.0 i 1.4 g/dL u odnosu na razinu pri prvom mjerenju; ili xi. ako je razina hemoglobina kod pacijenta pri drugom mjerenju između 12.3 i 12.9 g/dL i ako je razina hemoglobina porasla za više od 1.5 g/dL u odnosu na razinu pri prvom mjerenju; tada c. davanje prilagođene dnevne doze spoja koje je veće od početne dnevne doze, poželjno 150 mg veća od početne dnevne doze.
12. Spoj za uporabu prema zahtjevu 11, naznačen time što je period između prvog i drugog mjerenja 1 dan, 2 dana, 3 dana, 4 dana, 5 dana, 6 dana, 7 dana, 8 dana, 9 dana, 10 dana, 11 dana, 12 dana, 13 dana, 14 dana, 3 tjedna, 4 tjedna, 5 tjedana, 6 tjedana, 7 tjedana, ili 8 tjedana.
13. Spoj za uporabu prema zahtjevu 11 ili 12, naznačen time što se prvo mjerenje vrši prije početka liječenja; ili odmah nakon početka liječenja ili unutar najviše 1 dana, 2 dana, 3 dana, 4 dana, 5 dana, 6 dana, ili 1 tjedna ,ili 2 tjedna nakon toga.
14. Spoj za uporabu prema bilo kojem od zahtjeva 1-13, naznačen time što se liječi bolest povezana sa smanjenom endogenom proizvodnjom eritropoetina (EPO), postupak sadrži davanje dovoljnog broja uzastopnih doza spoja 1, tako da se povisi ukupan kapacitet vezivanja željeza (TIBC) u odnosu na osnovni TIBC kod pacijenta, bez značajnog povećanja razine željeza u serumu u odnosu na početnu razinu željeza u serumu, poželjno pri čemu su kardiovaskularne nuspojave i rizik od tromboembolijskih događaja povezanih s povišenim razinama željeza u serumu svedeni na minimum.
15. Spoj za uporabu prema zahtjevu 14, naznačen time što se zasićenje transferina (TSAT) smanjuje u odnosu na osnovnu liniju TSAT, i/ili gdje se razina željeza u serumu smanjuje u odnosu na osnovnu razinu željeza u serumu, poželjno pri čemu se razina željeza u serumu povećava za manje od 20 µg/dL, manje od 15 µg/dL, manje od 10 µg/dL, ili manje od 5 µg/dL u odnosu na osnovnu razinu željeza u serumu; i/ili pri čemu se TIBC povećava za najmanje 10 µg/dL, 20 µg/dL, 30 µg/dL, 40 µg/dL, 50 µg/dL, ili najmanje 60 µg/dL u odnosu na osnovni TIBC, poželjno pri čemu povećanje TIBC-a događa se tijekom 1 tjedna, 2 tjedna, 3 tjedna, 4 tjedna, 5 tjedana, ili 6 tjedana u odnosu na početni TIBC.
16. Spoj za uporabu prema bilo kojem od zahtjeva 1-15, naznačen time što je spoj formuliran kao jedinični oblik doziranja koji sadrži 150 mg, 300 mg, ili 450 mg spoja.
HRP20240319TT 2013-06-13 2014-06-04 Pripravci i postupci za liječenje anemije HRP20240319T1 (hr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201361834808P 2013-06-13 2013-06-13
US201361889478P 2013-10-10 2013-10-10
US201361898890P 2013-11-01 2013-11-01
US201361898885P 2013-11-01 2013-11-01
US201361912185P 2013-12-05 2013-12-05
PCT/US2014/040889 WO2014200773A2 (en) 2013-06-13 2014-06-04 Compositions and methods for treating anemia
EP14811317.8A EP3007695B1 (en) 2013-06-13 2014-06-04 Compositions and methods for treating anemia

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HRP20240319T1 true HRP20240319T1 (hr) 2024-05-24

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US (2) US11857543B2 (hr)
EP (2) EP3007695B1 (hr)
JP (5) JP2016521747A (hr)
KR (4) KR102461176B1 (hr)
CN (3) CN114404413A (hr)
AU (4) AU2014278543B2 (hr)
BR (1) BR112015031027A2 (hr)
CA (2) CA2914662C (hr)
CL (2) CL2015003602A1 (hr)
CY (2) CY1126699T1 (hr)
DK (1) DK3007695T3 (hr)
DO (1) DOP2015000297A (hr)
EC (1) ECSP20058592A (hr)
ES (1) ES2974273T3 (hr)
FI (2) FI3007695T3 (hr)
FR (1) FR24C1025I2 (hr)
HR (1) HRP20240319T1 (hr)
HU (2) HUE066123T2 (hr)
IL (3) IL243047B (hr)
LT (1) LT3007695T (hr)
MX (3) MX378150B (hr)
MY (1) MY204336A (hr)
NL (1) NL301278I2 (hr)
NO (1) NO2024025I1 (hr)
NZ (3) NZ714963A (hr)
PE (2) PE20201496A1 (hr)
PH (2) PH12015502738B1 (hr)
PL (1) PL3007695T3 (hr)
PT (1) PT3007695T (hr)
RS (1) RS65341B1 (hr)
RU (2) RU2705206C2 (hr)
SG (2) SG11201509998WA (hr)
SI (1) SI3007695T1 (hr)
SM (1) SMT202400092T1 (hr)
TW (5) TWI650126B (hr)
WO (1) WO2014200773A2 (hr)
ZA (1) ZA201509024B (hr)

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JP2023501221A (ja) 2019-10-31 2023-01-18 アケビア セラピューティクス インコーポレイテッド バダデュスタットを使用する治療方法
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