Ozanimod: First Approval
Ozanimod (ZEPOSIA ® ; Celgene Corporation) is a novel, orally administered sphingosine 1-phosphate (S1P) receptor modulator. In March 2020, the US FDA approved ozanimod capsules for use in the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing–remi...
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| Veröffentlicht in: | Drugs (New York, N.Y.) N.Y.), 2020-06, Vol.80 (8), p.841-848 |
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| container_title | Drugs (New York, N.Y.) |
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| creator | Lamb, Yvette N. |
| description | Ozanimod (ZEPOSIA
®
; Celgene Corporation) is a novel, orally administered sphingosine 1-phosphate (S1P) receptor modulator. In March 2020, the US FDA approved ozanimod capsules for use in the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing–remitting disease, and active secondary progressive disease, in adults. In the same month, ozanimod received a positive CHMP opinion recommending approval in the EU for the treatment of adult patients with relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features. Ozanimod is currently being evaluated for use in ulcerative colitis and Crohn’s disease in multinational phase III trials. This article summarizes the milestones in the development of ozanimod leading to its first approval for relapsing forms of multiple sclerosis. |
| doi_str_mv | 10.1007/s40265-020-01319-7 |
| format | Article |
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; Celgene Corporation) is a novel, orally administered sphingosine 1-phosphate (S1P) receptor modulator. In March 2020, the US FDA approved ozanimod capsules for use in the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing–remitting disease, and active secondary progressive disease, in adults. In the same month, ozanimod received a positive CHMP opinion recommending approval in the EU for the treatment of adult patients with relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features. Ozanimod is currently being evaluated for use in ulcerative colitis and Crohn’s disease in multinational phase III trials. This article summarizes the milestones in the development of ozanimod leading to its first approval for relapsing forms of multiple sclerosis.</description><identifier>ISSN: 0012-6667</identifier><identifier>EISSN: 1179-1950</identifier><identifier>DOI: 10.1007/s40265-020-01319-7</identifier><identifier>PMID: 32385738</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>AdisInsight Report ; Administration, Oral ; Adults ; Agreements ; Blood pressure ; Clinical trials ; Contraindications ; Crohn's disease ; Drug Approval ; Edema ; Health services ; Heart failure ; Heart rate ; Humans ; Indans - administration & dosage ; Indans - chemistry ; Indans - pharmacology ; Inflammatory bowel disease ; Internal Medicine ; Licenses ; Lymphocytes ; Medicine ; Medicine & Public Health ; Molecular Structure ; Multiple sclerosis ; Multiple Sclerosis, Relapsing-Remitting - drug therapy ; Multiple Sclerosis, Relapsing-Remitting - metabolism ; Oral administration ; Oxadiazoles - administration & dosage ; Oxadiazoles - chemistry ; Oxadiazoles - pharmacology ; Pharmacology/Toxicology ; Pharmacotherapy ; Sphingosine 1 Phosphate Receptor Modulators - administration & dosage ; Sphingosine 1 Phosphate Receptor Modulators - chemistry ; Sphingosine 1 Phosphate Receptor Modulators - pharmacology ; Sphingosine 1-phosphate ; Sphingosine-1-Phosphate Receptors - metabolism ; Ulcerative colitis</subject><ispartof>Drugs (New York, N.Y.), 2020-06, Vol.80 (8), p.841-848</ispartof><rights>Springer Nature Switzerland AG 2020</rights><rights>Copyright Springer Nature B.V. Jun 2020</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-7389d55b4f2b08151243bd94c937360f0cd42f6e7b6422b30b3f85be349b1c3f3</citedby><cites>FETCH-LOGICAL-c375t-7389d55b4f2b08151243bd94c937360f0cd42f6e7b6422b30b3f85be349b1c3f3</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/s40265-020-01319-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40265-020-01319-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32385738$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lamb, Yvette N.</creatorcontrib><title>Ozanimod: First Approval</title><title>Drugs (New York, N.Y.)</title><addtitle>Drugs</addtitle><addtitle>Drugs</addtitle><description>Ozanimod (ZEPOSIA
®
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This article summarizes the milestones in the development of ozanimod leading to its first approval for relapsing forms of multiple sclerosis.</description><subject>AdisInsight Report</subject><subject>Administration, Oral</subject><subject>Adults</subject><subject>Agreements</subject><subject>Blood pressure</subject><subject>Clinical trials</subject><subject>Contraindications</subject><subject>Crohn's disease</subject><subject>Drug Approval</subject><subject>Edema</subject><subject>Health services</subject><subject>Heart failure</subject><subject>Heart rate</subject><subject>Humans</subject><subject>Indans - administration & dosage</subject><subject>Indans - chemistry</subject><subject>Indans - pharmacology</subject><subject>Inflammatory bowel disease</subject><subject>Internal Medicine</subject><subject>Licenses</subject><subject>Lymphocytes</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Molecular Structure</subject><subject>Multiple sclerosis</subject><subject>Multiple Sclerosis, Relapsing-Remitting - drug therapy</subject><subject>Multiple Sclerosis, Relapsing-Remitting - metabolism</subject><subject>Oral administration</subject><subject>Oxadiazoles - administration & dosage</subject><subject>Oxadiazoles - chemistry</subject><subject>Oxadiazoles - pharmacology</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Sphingosine 1 Phosphate Receptor Modulators - administration & dosage</subject><subject>Sphingosine 1 Phosphate Receptor Modulators - chemistry</subject><subject>Sphingosine 1 Phosphate Receptor Modulators - pharmacology</subject><subject>Sphingosine 1-phosphate</subject><subject>Sphingosine-1-Phosphate Receptors - metabolism</subject><subject>Ulcerative colitis</subject><issn>0012-6667</issn><issn>1179-1950</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kE1LAzEQhoMotlbv4kEEL16ik--Nt1KsCoVe9Bw2u4ls2Y-adAX99aZuVfDgaRjmmXeGB6EzAtcEQN1EDlQKDBQwEEY0VntoTIjSmGgB-2gMQCiWUqoROopxtW210IdoxCjLhGLZGJ0uP_K2arry9mJehbi5mK7XoXvL62N04PM6upNdnaDn-d3T7AEvlvePs-kCF0yJDU4huhTCck8tZEQQypktNS80U0yCh6Lk1EunrOSUWgaW-UxYx7i2pGCeTdDVkJvOvvYubkxTxcLVdd66ro-GcgBBlMxkQi__oKuuD236bktJmV4RkCg6UEXoYgzOm3Womjy8GwJm680M3kzyZr68GZWWznfRvW1c-bPyLSoBbABiGrUvLvze_if2EyWOdGw</recordid><startdate>20200601</startdate><enddate>20200601</enddate><creator>Lamb, Yvette N.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><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>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20200601</creationdate><title>Ozanimod: First Approval</title><author>Lamb, Yvette N.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-7389d55b4f2b08151243bd94c937360f0cd42f6e7b6422b30b3f85be349b1c3f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>AdisInsight Report</topic><topic>Administration, Oral</topic><topic>Adults</topic><topic>Agreements</topic><topic>Blood pressure</topic><topic>Clinical trials</topic><topic>Contraindications</topic><topic>Crohn's disease</topic><topic>Drug Approval</topic><topic>Edema</topic><topic>Health services</topic><topic>Heart failure</topic><topic>Heart rate</topic><topic>Humans</topic><topic>Indans - 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| fulltext | fulltext |
| identifier | ISSN: 0012-6667 |
| ispartof | Drugs (New York, N.Y.), 2020-06, Vol.80 (8), p.841-848 |
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| source | MEDLINE; SpringerLink Journals |
| subjects | AdisInsight Report Administration, Oral Adults Agreements Blood pressure Clinical trials Contraindications Crohn's disease Drug Approval Edema Health services Heart failure Heart rate Humans Indans - administration & dosage Indans - chemistry Indans - pharmacology Inflammatory bowel disease Internal Medicine Licenses Lymphocytes Medicine Medicine & Public Health Molecular Structure Multiple sclerosis Multiple Sclerosis, Relapsing-Remitting - drug therapy Multiple Sclerosis, Relapsing-Remitting - metabolism Oral administration Oxadiazoles - administration & dosage Oxadiazoles - chemistry Oxadiazoles - pharmacology Pharmacology/Toxicology Pharmacotherapy Sphingosine 1 Phosphate Receptor Modulators - administration & dosage Sphingosine 1 Phosphate Receptor Modulators - chemistry Sphingosine 1 Phosphate Receptor Modulators - pharmacology Sphingosine 1-phosphate Sphingosine-1-Phosphate Receptors - metabolism Ulcerative colitis |
| title | Ozanimod: First Approval |
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