Istradefylline: First Global Approval
Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A 2A receptor antagonist, for the once-daily oral treatment of Parkinson’s disease (PD). Adenosine A 2A receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observe...
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| Veröffentlicht in: | Drugs (New York, N.Y.) N.Y.), 2013-06, Vol.73 (8), p.875-882 |
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| creator | Dungo, Rosselle Deeks, Emma D. |
| description | Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A
2A
receptor antagonist, for the once-daily oral treatment of Parkinson’s disease (PD). Adenosine A
2A
receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observed in PD is believed to occur in the basal ganglia, which is recognized to play a significant role in motor control. Commercially available dopamine replacement therapies effectively treat the early motor symptoms of PD; however, these agents are associated with development of motor complications, limiting usefulness in late stages of the disease. Istradefylline is proposed to possess a clearly distinct action site from existing agents which act on dopamine metabolism or dopamine receptors. Kyowa Hakko Kirin has received approval for istradefylline in the adjunctive treatment of PD in Japan. A New Drug Application was filed in the USA, but the FDA issued a non-approvable letter in February 2008. This article summarizes the milestones in the development of istradefylline leading to its first approval for the treatment of patients with PD. |
| doi_str_mv | 10.1007/s40265-013-0066-7 |
| format | Article |
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2A
receptor antagonist, for the once-daily oral treatment of Parkinson’s disease (PD). Adenosine A
2A
receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observed in PD is believed to occur in the basal ganglia, which is recognized to play a significant role in motor control. Commercially available dopamine replacement therapies effectively treat the early motor symptoms of PD; however, these agents are associated with development of motor complications, limiting usefulness in late stages of the disease. Istradefylline is proposed to possess a clearly distinct action site from existing agents which act on dopamine metabolism or dopamine receptors. Kyowa Hakko Kirin has received approval for istradefylline in the adjunctive treatment of PD in Japan. A New Drug Application was filed in the USA, but the FDA issued a non-approvable letter in February 2008. This article summarizes the milestones in the development of istradefylline leading to its first approval for the treatment of patients with PD.</description><identifier>ISSN: 0012-6667</identifier><identifier>EISSN: 1179-1950</identifier><identifier>DOI: 10.1007/s40265-013-0066-7</identifier><identifier>PMID: 23700273</identifier><identifier>CODEN: DRUGAY</identifier><language>eng</language><publisher>Cham: Springer International Publishing AG</publisher><subject>Adenosine ; Adenosine A2 Receptor Antagonists - pharmacokinetics ; Adenosine A2 Receptor Antagonists - pharmacology ; Agreements ; Anticonvulsants. Antiepileptics. Antiparkinson agents ; Basal Ganglia - drug effects ; Basal Ganglia - metabolism ; Biological and medical sciences ; Brain ; Dopamine ; Dopamine - metabolism ; Drug Approval ; Drug dosages ; Dyskinesia ; Humans ; Internal Medicine ; Japan ; Medical sciences ; Medicine ; Medicine & Public Health ; Neuropharmacology ; Oral administration ; Parkinson Disease - drug therapy ; Parkinson Disease - metabolism ; Parkinson's disease ; Pharmaceuticals ; Pharmacokinetics ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Pharmacotherapy ; Purines - pharmacokinetics ; Purines - pharmacology ; R & D Insight Report</subject><ispartof>Drugs (New York, N.Y.), 2013-06, Vol.73 (8), p.875-882</ispartof><rights>Springer International Publishing Switzerland 2013</rights><rights>2014 INIST-CNRS</rights><rights>Copyright Wolters Kluwer Health Adis International Jun 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c402t-bb2b09c9fc89145dd5704b5ac7e577dfae4831c95f7f7719362762f0ce30a23c3</citedby><cites>FETCH-LOGICAL-c402t-bb2b09c9fc89145dd5704b5ac7e577dfae4831c95f7f7719362762f0ce30a23c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40265-013-0066-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40265-013-0066-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27922,27923,41486,42555,51317</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27483736$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23700273$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dungo, Rosselle</creatorcontrib><creatorcontrib>Deeks, Emma D.</creatorcontrib><title>Istradefylline: First Global Approval</title><title>Drugs (New York, N.Y.)</title><addtitle>Drugs</addtitle><addtitle>Drugs</addtitle><description>Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A
2A
receptor antagonist, for the once-daily oral treatment of Parkinson’s disease (PD). Adenosine A
2A
receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observed in PD is believed to occur in the basal ganglia, which is recognized to play a significant role in motor control. Commercially available dopamine replacement therapies effectively treat the early motor symptoms of PD; however, these agents are associated with development of motor complications, limiting usefulness in late stages of the disease. Istradefylline is proposed to possess a clearly distinct action site from existing agents which act on dopamine metabolism or dopamine receptors. Kyowa Hakko Kirin has received approval for istradefylline in the adjunctive treatment of PD in Japan. A New Drug Application was filed in the USA, but the FDA issued a non-approvable letter in February 2008. This article summarizes the milestones in the development of istradefylline leading to its first approval for the treatment of patients with PD.</description><subject>Adenosine</subject><subject>Adenosine A2 Receptor Antagonists - pharmacokinetics</subject><subject>Adenosine A2 Receptor Antagonists - pharmacology</subject><subject>Agreements</subject><subject>Anticonvulsants. Antiepileptics. Antiparkinson agents</subject><subject>Basal Ganglia - drug effects</subject><subject>Basal Ganglia - metabolism</subject><subject>Biological and medical sciences</subject><subject>Brain</subject><subject>Dopamine</subject><subject>Dopamine - metabolism</subject><subject>Drug Approval</subject><subject>Drug dosages</subject><subject>Dyskinesia</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Japan</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Neuropharmacology</subject><subject>Oral administration</subject><subject>Parkinson Disease - drug therapy</subject><subject>Parkinson Disease - metabolism</subject><subject>Parkinson's disease</subject><subject>Pharmaceuticals</subject><subject>Pharmacokinetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Purines - pharmacokinetics</subject><subject>Purines - pharmacology</subject><subject>R & D Insight Report</subject><issn>0012-6667</issn><issn>1179-1950</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kE1LAzEQhoMotlZ_gBcpSI-rk2STabyVorVQ8KLnkM0msmW7W5Ot0H9vytaPi6cw5Jl5Xx5CrincUQC8jzkwKTKgPAOQMsMTMqQUVUaVgFMyBKAsk1LigFzEuD6MSqhzMmAcARjyIZksYxdM6fy-rqvGPYyfqhC78aJuC1OPZ9ttaD9NfUnOvKmjuzq-I_L29Pg6f85WL4vlfLbKbGrSZUXBClBWeTtVNBdlKRDyQhiLTiCW3rh8yqlVwqNHpIpLhpJ5sI6DYdzyEbnt76bYj52LnV63u9CkSE1zKZlQUvBE0Z6yoY0xOK-3odqYsNcU9EGM7sXoJEYfxGhMOzfHy7ti48qfjW8TCZgcAROtqX0wja3iL4epOnKZONZzMX017y78qfhv-hdD53hZ</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>Dungo, Rosselle</creator><creator>Deeks, Emma D.</creator><general>Springer International Publishing AG</general><general>Adis International</general><general>Springer Nature B.V</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7QO</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20130601</creationdate><title>Istradefylline: First Global Approval</title><author>Dungo, Rosselle ; Deeks, Emma D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c402t-bb2b09c9fc89145dd5704b5ac7e577dfae4831c95f7f7719362762f0ce30a23c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adenosine</topic><topic>Adenosine A2 Receptor Antagonists - pharmacokinetics</topic><topic>Adenosine A2 Receptor Antagonists - pharmacology</topic><topic>Agreements</topic><topic>Anticonvulsants. Antiepileptics. Antiparkinson agents</topic><topic>Basal Ganglia - drug effects</topic><topic>Basal Ganglia - metabolism</topic><topic>Biological and medical sciences</topic><topic>Brain</topic><topic>Dopamine</topic><topic>Dopamine - metabolism</topic><topic>Drug Approval</topic><topic>Drug dosages</topic><topic>Dyskinesia</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Japan</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Neuropharmacology</topic><topic>Oral administration</topic><topic>Parkinson Disease - drug therapy</topic><topic>Parkinson Disease - metabolism</topic><topic>Parkinson's disease</topic><topic>Pharmaceuticals</topic><topic>Pharmacokinetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Purines - pharmacokinetics</topic><topic>Purines - pharmacology</topic><topic>R & D Insight Report</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dungo, Rosselle</creatorcontrib><creatorcontrib>Deeks, Emma D.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Drugs (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dungo, Rosselle</au><au>Deeks, Emma D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Istradefylline: First Global Approval</atitle><jtitle>Drugs (New York, N.Y.)</jtitle><stitle>Drugs</stitle><addtitle>Drugs</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>73</volume><issue>8</issue><spage>875</spage><epage>882</epage><pages>875-882</pages><issn>0012-6667</issn><eissn>1179-1950</eissn><coden>DRUGAY</coden><abstract>Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A
2A
receptor antagonist, for the once-daily oral treatment of Parkinson’s disease (PD). Adenosine A
2A
receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observed in PD is believed to occur in the basal ganglia, which is recognized to play a significant role in motor control. Commercially available dopamine replacement therapies effectively treat the early motor symptoms of PD; however, these agents are associated with development of motor complications, limiting usefulness in late stages of the disease. Istradefylline is proposed to possess a clearly distinct action site from existing agents which act on dopamine metabolism or dopamine receptors. Kyowa Hakko Kirin has received approval for istradefylline in the adjunctive treatment of PD in Japan. A New Drug Application was filed in the USA, but the FDA issued a non-approvable letter in February 2008. This article summarizes the milestones in the development of istradefylline leading to its first approval for the treatment of patients with PD.</abstract><cop>Cham</cop><pub>Springer International Publishing AG</pub><pmid>23700273</pmid><doi>10.1007/s40265-013-0066-7</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0012-6667 |
| ispartof | Drugs (New York, N.Y.), 2013-06, Vol.73 (8), p.875-882 |
| issn | 0012-6667 1179-1950 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adenosine Adenosine A2 Receptor Antagonists - pharmacokinetics Adenosine A2 Receptor Antagonists - pharmacology Agreements Anticonvulsants. Antiepileptics. Antiparkinson agents Basal Ganglia - drug effects Basal Ganglia - metabolism Biological and medical sciences Brain Dopamine Dopamine - metabolism Drug Approval Drug dosages Dyskinesia Humans Internal Medicine Japan Medical sciences Medicine Medicine & Public Health Neuropharmacology Oral administration Parkinson Disease - drug therapy Parkinson Disease - metabolism Parkinson's disease Pharmaceuticals Pharmacokinetics Pharmacology. Drug treatments Pharmacology/Toxicology Pharmacotherapy Purines - pharmacokinetics Purines - pharmacology R & D Insight Report |
| title | Istradefylline: First Global Approval |
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