{"id":1095,"date":"2022-09-13T19:56:16","date_gmt":"2022-09-13T19:56:16","guid":{"rendered":"https:\/\/vimizimhcp-dev-001.azurewebsites.net\/en-us\/vimizim\/?page_id=1095"},"modified":"2023-05-03T11:43:33","modified_gmt":"2023-05-03T11:43:33","slug":"pulmonary-function","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/vimizim\/pulmonary-function\/","title":{"rendered":"Pulmonary Function"},"content":{"rendered":"
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VIMIZIM\u00ae<\/sup> (elosulfase alfa) showed sustained improvement in pulmonary function at 120 weeks1<\/sup><\/h1>\n <\/div>\n<\/div>\n\n
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All Patients<\/h2>\n

VIMIZIM\u00ae<\/sup> (elosulfase alfa) demonstrated significant and sustained improvement in exploratory endpoints at week 1201,2<\/sup><\/h3>\n

MOR-005 was an open-label, long-term extension study that included a staggered titration to the weekly dosing regimen. In the absence of a placebo group, significance of the sustained improvements could not be evaluated directly.1<\/sup><\/p>\n <\/div>\n\n

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FEV1<\/sub><\/strong>, forced expiratory volume in 1 second; FVC<\/strong>, forced vital capacity; LS,<\/strong> least squares; MPP<\/strong>, modified per protocol; MVV<\/strong>, maximum voluntary ventilation.<\/p>\n

Understand the natural history study<\/a> cohort.<\/p>\n<\/figcaption>\n <\/figure>\n <\/div>\n <\/div>\n<\/div>\n\n

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Older Patients<\/h2>\n

Pulmonary function was maintained in patients older than age 141<\/sup><\/h3>\n

VIMIZIM\u00ae<\/sup> (elosulfase alfa) showed improved pulmonary function in older patients1<\/sup><\/strong><\/p>\n

Subgroup analysis showed sustained improvement in the exploratory endpoints (FVC and FEV1<\/sub>).1<\/sup><\/p>\n

MOR-005 was an open-label, long-term extension study that included a staggered titration to the weekly dosing regimen. In the absence of a placebo group, significance of the sustained improvements could not be evaluated directly.1,2<\/sup><\/p>\n

The improvements in respiratory function in patients \u226414 years may be in part related to growth.1<\/sup><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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FEV1<\/sub>,<\/strong> forced expiratory volume in 1 second; FVC,<\/strong> forced vital capacity; LS,<\/strong> least squares; NS<\/strong>, not significant.<\/small><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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Review the designs of the pivotal phase 3 and long-term extension studies of VIMIZIM<\/a><\/p>\n <\/div>\n<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n

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References:\n<\/h4>\n\t\t\t\t\t\t
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  1. Hendriksz CJ, Berger KI, Parini R, et al<\/em>. Impact of long-term elosulfase alfa treatment on respiratory function in patients with Morquio A syndrome. J Inherit Metab Dis<\/em>. 2016;39(6):839-847. \n<\/span><\/li>\n
  2. \n\nVIMIZIM [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2019.\n\n\n<\/span><\/li>\n <\/ol>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-1095","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nVIMIZIM\u00ae (elosulfase alfa) | Study Results<\/title>\n<meta name=\"description\" content=\"VIMIZIM\u00ae (elosulfase alfa) showed sustained improvement in pulmonary function. Review the long-term extension study results. 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