Efgartigimod: First Approval
Efgartigimod (efgartigimod alfa-fcab, Vyvgart ™ ) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of...
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| Veröffentlicht in: | Drugs (New York, N.Y.) N.Y.), 2022-02, Vol.82 (3), p.341-348 |
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| creator | Heo, Young-A |
| description | Efgartigimod (efgartigimod alfa-fcab, Vyvgart
™
) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. Intravenous efgartigimod has also been evaluated for generalized myasthenia gravis in various other countries, with the agent subsequently approved in Japan in January 2022 for generalized myasthenia gravis patients regardless of antibody status and in preregistration stage in the EU. Several clinical studies of intravenous and subcutaneous formulation of efgartigimod are also being investigated for other autoimmune diseases including bullous pemphigoid, chronic inflammatory demyelinating polyradiculoneuropathy, immune thrombocytopenia, autoimmune myositis and pemphigus. This article summarizes the milestones in the development of efgartigimod leading to this first approval for generalized myasthenia gravis. |
| doi_str_mv | 10.1007/s40265-022-01678-3 |
| format | Article |
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™
) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. Intravenous efgartigimod has also been evaluated for generalized myasthenia gravis in various other countries, with the agent subsequently approved in Japan in January 2022 for generalized myasthenia gravis patients regardless of antibody status and in preregistration stage in the EU. Several clinical studies of intravenous and subcutaneous formulation of efgartigimod are also being investigated for other autoimmune diseases including bullous pemphigoid, chronic inflammatory demyelinating polyradiculoneuropathy, immune thrombocytopenia, autoimmune myositis and pemphigus. This article summarizes the milestones in the development of efgartigimod leading to this first approval for generalized myasthenia gravis.</description><identifier>ISSN: 0012-6667</identifier><identifier>EISSN: 1179-1950</identifier><identifier>DOI: 10.1007/s40265-022-01678-3</identifier><identifier>PMID: 35179720</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Acetylcholine receptors ; AdisInsight Report ; Adult ; Antibodies ; Antibodies, Monoclonal, Humanized ; Autoantibodies ; Autoimmune diseases ; Bullous pemphigoid ; Collaboration ; Demyelination ; Fc receptors ; Health services ; Humans ; Idiopathic thrombocytopenic purpura ; Immunoglobulins ; Infant, Newborn ; Inflammation ; Internal Medicine ; Intravenous administration ; Medicine ; Medicine & Public Health ; Myasthenia ; Myasthenia gravis ; Myasthenia Gravis - drug therapy ; Myositis ; Neonates ; Neuromuscular junctions ; Partnership agreements ; Pemphigus ; Pharmacology/Toxicology ; Pharmacotherapy ; Proprietary ; Purpura, Thrombocytopenic, Idiopathic ; Receptors ; Receptors, Cholinergic ; Royalties ; Thrombocytopenia ; Vaccines</subject><ispartof>Drugs (New York, N.Y.), 2022-02, Vol.82 (3), p.341-348</ispartof><rights>Springer Nature 2022. corrected publication 2022</rights><rights>2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.</rights><rights>Copyright Springer Nature B.V. Feb 2022</rights><rights>Springer Nature 2022, corrected publication 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-d94d0f184c35cdea5f63b602ebecd01570135e5413edf38d6547102bba1f03673</citedby><cites>FETCH-LOGICAL-c474t-d94d0f184c35cdea5f63b602ebecd01570135e5413edf38d6547102bba1f03673</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/s40265-022-01678-3$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40265-022-01678-3$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35179720$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Heo, Young-A</creatorcontrib><title>Efgartigimod: First Approval</title><title>Drugs (New York, N.Y.)</title><addtitle>Drugs</addtitle><addtitle>Drugs</addtitle><description>Efgartigimod (efgartigimod alfa-fcab, Vyvgart
™
) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. Intravenous efgartigimod has also been evaluated for generalized myasthenia gravis in various other countries, with the agent subsequently approved in Japan in January 2022 for generalized myasthenia gravis patients regardless of antibody status and in preregistration stage in the EU. Several clinical studies of intravenous and subcutaneous formulation of efgartigimod are also being investigated for other autoimmune diseases including bullous pemphigoid, chronic inflammatory demyelinating polyradiculoneuropathy, immune thrombocytopenia, autoimmune myositis and pemphigus. This article summarizes the milestones in the development of efgartigimod leading to this first approval for generalized myasthenia gravis.</description><subject>Acetylcholine receptors</subject><subject>AdisInsight Report</subject><subject>Adult</subject><subject>Antibodies</subject><subject>Antibodies, Monoclonal, Humanized</subject><subject>Autoantibodies</subject><subject>Autoimmune diseases</subject><subject>Bullous pemphigoid</subject><subject>Collaboration</subject><subject>Demyelination</subject><subject>Fc receptors</subject><subject>Health services</subject><subject>Humans</subject><subject>Idiopathic thrombocytopenic purpura</subject><subject>Immunoglobulins</subject><subject>Infant, Newborn</subject><subject>Inflammation</subject><subject>Internal Medicine</subject><subject>Intravenous administration</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Myasthenia</subject><subject>Myasthenia gravis</subject><subject>Myasthenia Gravis - drug therapy</subject><subject>Myositis</subject><subject>Neonates</subject><subject>Neuromuscular junctions</subject><subject>Partnership agreements</subject><subject>Pemphigus</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Proprietary</subject><subject>Purpura, Thrombocytopenic, Idiopathic</subject><subject>Receptors</subject><subject>Receptors, Cholinergic</subject><subject>Royalties</subject><subject>Thrombocytopenia</subject><subject>Vaccines</subject><issn>0012-6667</issn><issn>1179-1950</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kE1Lw0AQhhdRbK3-ARERvHiJzn4nHoRSWhUKXvS8bJJNTMlH3U0K_ns3ptaPg6dlmGfenXkQOsVwjQHkjWNABA-AkACwkGFA99AYYxkFOOKwj8YAmARCCDlCR86t-jLi0SEaUe4pSWCMzuZZrm1b5EXVpLcXi8K69mK6Xttmo8tjdJDp0pmT7TtBL4v58-whWD7dP86myyBhkrVBGrEUMhyyhPIkNZpngsYCiIlNkgLmEjDlhjNMTZrRMBWcSQwkjjXOgApJJ-huyF13cWXSxNSt1aVa26LS9l01ulC_O3XxqvJmo8KQc8GYD7jaBtjmrTOuVVXhElOWujZN5xQRFCIKlAqPXv5BV01na39eT3G_WiSop8hAJbZxzppstwwG1ctXg3zl5atP-aofOv95xm7ky7YH6AA436pzY7___if2A33xjeA</recordid><startdate>20220201</startdate><enddate>20220201</enddate><creator>Heo, Young-A</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20220201</creationdate><title>Efgartigimod: First Approval</title><author>Heo, Young-A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-d94d0f184c35cdea5f63b602ebecd01570135e5413edf38d6547102bba1f03673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Acetylcholine receptors</topic><topic>AdisInsight Report</topic><topic>Adult</topic><topic>Antibodies</topic><topic>Antibodies, Monoclonal, Humanized</topic><topic>Autoantibodies</topic><topic>Autoimmune diseases</topic><topic>Bullous pemphigoid</topic><topic>Collaboration</topic><topic>Demyelination</topic><topic>Fc receptors</topic><topic>Health services</topic><topic>Humans</topic><topic>Idiopathic thrombocytopenic purpura</topic><topic>Immunoglobulins</topic><topic>Infant, Newborn</topic><topic>Inflammation</topic><topic>Internal Medicine</topic><topic>Intravenous administration</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Myasthenia</topic><topic>Myasthenia gravis</topic><topic>Myasthenia Gravis - drug therapy</topic><topic>Myositis</topic><topic>Neonates</topic><topic>Neuromuscular junctions</topic><topic>Partnership agreements</topic><topic>Pemphigus</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Proprietary</topic><topic>Purpura, Thrombocytopenic, Idiopathic</topic><topic>Receptors</topic><topic>Receptors, Cholinergic</topic><topic>Royalties</topic><topic>Thrombocytopenia</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Heo, Young-A</creatorcontrib><collection>Springer Nature OA Free Journals</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>ProQuest Nursing and Allied Health Journals</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection (Proquest)</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)</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>PML(ProQuest Medical Library)</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>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Drugs (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Heo, Young-A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efgartigimod: First Approval</atitle><jtitle>Drugs (New York, N.Y.)</jtitle><stitle>Drugs</stitle><addtitle>Drugs</addtitle><date>2022-02-01</date><risdate>2022</risdate><volume>82</volume><issue>3</issue><spage>341</spage><epage>348</epage><pages>341-348</pages><issn>0012-6667</issn><eissn>1179-1950</eissn><abstract>Efgartigimod (efgartigimod alfa-fcab, Vyvgart
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) is a first-in-class neonatal Fc receptor antagonist being developed by argenx for the treatment of autoimmune diseases including myasthenia gravis. In December 2021, intravenous efgartigimod received its first approval in the USA for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. Intravenous efgartigimod has also been evaluated for generalized myasthenia gravis in various other countries, with the agent subsequently approved in Japan in January 2022 for generalized myasthenia gravis patients regardless of antibody status and in preregistration stage in the EU. Several clinical studies of intravenous and subcutaneous formulation of efgartigimod are also being investigated for other autoimmune diseases including bullous pemphigoid, chronic inflammatory demyelinating polyradiculoneuropathy, immune thrombocytopenia, autoimmune myositis and pemphigus. This article summarizes the milestones in the development of efgartigimod leading to this first approval for generalized myasthenia gravis.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>35179720</pmid><doi>10.1007/s40265-022-01678-3</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Drugs (New York, N.Y.), 2022-02, Vol.82 (3), p.341-348 |
| issn | 0012-6667 1179-1950 |
| language | eng |
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| source | MEDLINE; SpringerLink (Online service) |
| subjects | Acetylcholine receptors AdisInsight Report Adult Antibodies Antibodies, Monoclonal, Humanized Autoantibodies Autoimmune diseases Bullous pemphigoid Collaboration Demyelination Fc receptors Health services Humans Idiopathic thrombocytopenic purpura Immunoglobulins Infant, Newborn Inflammation Internal Medicine Intravenous administration Medicine Medicine & Public Health Myasthenia Myasthenia gravis Myasthenia Gravis - drug therapy Myositis Neonates Neuromuscular junctions Partnership agreements Pemphigus Pharmacology/Toxicology Pharmacotherapy Proprietary Purpura, Thrombocytopenic, Idiopathic Receptors Receptors, Cholinergic Royalties Thrombocytopenia Vaccines |
| title | Efgartigimod: First Approval |
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