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FDA approves GSK’s Ojjaara for the treatment of patients with myelofibrosis and anaemia
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Sans"" class="Widget-module_outer__PBh8P Page-module_outer__g0XXH"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%"><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>NEWS</p></div></div><div id="outer" data-widget="heading-widget" style="background-color:transparent;padding:0px 24px 16px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Heading-module_container__uHf-4"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%"><h2><span style="font-family:"Roboto Slab"" class="__bold">FDA approves GSK’s Ojjaara for the treatment of patients with myelofibrosis and anaemia</span></h2></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p><span class="__bold">GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia. </span></p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>Ojjaara is a once-daily oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor and is currently the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that treats the key manifestations of the disease, including anaemia, constitutional symptoms and splenomegaly (enlarged spleen).</p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>The FDA’s approval of the drug follows data from the MOMENTUM trial and a sub-population of patients with anaemia in the SIMPLIFY-1 phase 3 trial. The MOMENTUM trial assessed the drug’s safety and efficacy, meeting all of its primary and key secondary endpoints and demonstrating statistically significant response. The most common adverse reactions in both trials were thrombocytopaenia, haemorrhage, bacterial infection, fatigue, dizziness, diarrhoea and nausea.</p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>Kapila Viges, CEO of Myeloproliferative Neoplasms (MPN) Research Foundation, added: “We are thrilled to see momelotinib reach the clinic, giving patients and their physicians another option to help manage myelofibrosis. Any new treatment that takes steps toward unlocking the mysteries of this complex and chronic blood cancer represents great progress for the field.”</p></div></div><div id="outer" data-widget="paragraph-widget" style="background-color:transparent;padding:0px 24px 8px 24px;text-align:left;font-size:100%;line-height:1.3;letter-spacing:0" class="Widget-module_outer__PBh8P Paragraph-module_container__-DJUN"><div id="inner" style="border-radius:0px 0px 0px 0px;width:100%;column-count:1"><p>Ruben A Mesa MD FACP, president and executive director of Atrium Health Levine Cancer Center and Atrium Health Wake Forest Baptist Comprehensive Cancer Center, US, stated: “With momelotinib we have the potential to establish a new standard of care for myelofibrosis patients with anaemia. Addressing key manifestations of myelofibrosis, including anaemia, constitutional symptoms and splenomegaly, makes a significant difference in the treatment regimen for these patients who have limited options to address these aspects of the disease.”</p></div></div></div></div></div><div class="_slug__share-button__ettip"><hr/></div></div></div><div id="ControlBar" class="_slug__control-bar__Jj4LE"><div class="WrapAutoHide-module_navigation__9sdQy WrapAutoHide-module_visible__UN7GD"><div class="ControlBar-module_toc-wrapper__AF5eD"><div class="ControlBar-module_toc__mKXnp"><div class="ControlBar-module_white-blur__TGapK"><div class="ControlBar-module_toc-slider__i9fv1"></div></div><div class="ControlBar-module_control-bar__9Zqak"><button class=""><svg xmlns="http://www.w3.org/2000/svg" width="24" height="24" viewBox="0 0 24 24" fill="none"><path d="M13.8287 19C13.5367 19 13.2467 18.873 13.0487 18.627L8.22066 12.627C7.92266 12.256 7.92666 11.726 8.23166 11.36L13.2317 5.35998C13.5847 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anaemia.","image":"https://cdn.magloft.com/pdf-import/921/images/pages/pg-006.jpg","cover":"https://cdn.magloft.com/publication-14881/screenshots/articles/237739.jpg?ts=1696237530","date":1696201200000,"unlockType":"free","categories":[],"pdfPageId":"2ATMWtT8EP5D","visible":true,"showOnToc":true,"bookmark":false,"position":8,"publicationId":14881,"pwaOptinId":null,"seoDescription":"Gsk has announced that the us food and drug administration (fda) has approved ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofib","classificationIds":[],"pwaSubscriptionIds":[],"source":"typeloft2","trending":false,"html":"\u003cpage-widget padding=\"16 0 24 0\"\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eNEWS\u003c/paragraph-widget\u003e\u003cheading-widget padding=\"0 24 16 24\" type=\"h2\"\u003e\u003cspan style=\"font-family: \u0026quot;Roboto Slab\u0026quot;;\" class=\"__bold\"\u003eFDA approves GSK’s Ojjaara for the treatment of patients with myelofibrosis and anaemia\u003c/span\u003e\u003c/heading-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003e\u003cspan class=\"__bold\"\u003eGSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia. \u003c/span\u003e\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eOjjaara is a once-daily oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor and is currently the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that treats the key manifestations of the disease, including anaemia, constitutional symptoms and splenomegaly (enlarged spleen).\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eThe FDA’s approval of the drug follows data from the MOMENTUM trial and a sub-population of patients with anaemia in the SIMPLIFY-1 phase 3 trial. The MOMENTUM trial assessed the drug’s safety and efficacy, meeting all of its primary and key secondary endpoints and demonstrating statistically significant response. The most common adverse reactions in both trials were thrombocytopaenia, haemorrhage, bacterial infection, fatigue, dizziness, diarrhoea and nausea.\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eKapila Viges, CEO of Myeloproliferative Neoplasms (MPN) Research Foundation, added: “We are thrilled to see momelotinib reach the clinic, giving patients and their physicians another option to help manage myelofibrosis. Any new treatment that takes steps toward unlocking the mysteries of this complex and chronic blood cancer represents great progress for the field.”\u003c/paragraph-widget\u003e\u003cparagraph-widget padding=\"0 24 8 24\"\u003eRuben A Mesa MD FACP, president and executive director of Atrium Health Levine Cancer Center and Atrium Health Wake Forest Baptist Comprehensive Cancer Center, US, stated: “With momelotinib we have the potential to establish a new standard of care for myelofibrosis patients with anaemia. Addressing key manifestations of myelofibrosis, including anaemia, constitutional symptoms and splenomegaly, makes a significant difference in the treatment regimen for these patients who have limited options to address these aspects of the disease.”\u003c/paragraph-widget\u003e\u003c/page-widget\u003e","keywordPhrase":"FDA approves GSK's Ojjaara for the","articleAssets":[{"url":"https://cdn.magloft.com/reader/fonts/roboto-slab.css","extension":"css","contentType":"text/css"},{"url":"https://cdn.magloft.com/reader/fonts/open-sans.css","extension":"css","contentType":"text/css"}]},"publicationId":14881},"__N_SSG":true},"page":"/domains/[domain]/articles/[slug]","query":{"domain":"magazine.pharmafile.com","slug":"fda-approves-gsk-s-ojjaara-for-the-treatment-of-patients-with-my"},"buildId":"1bBCYhXOG7wsYuaBifvjK","isFallback":false,"gsp":true,"scriptLoader":[]}</script></body></html>