{"id":56027,"date":"2026-02-02T17:02:31","date_gmt":"2026-02-02T09:02:31","guid":{"rendered":"https:\/\/flcube.com\/?p=56027"},"modified":"2026-02-02T17:02:31","modified_gmt":"2026-02-02T09:02:31","slug":"chiesi-fabry-drug-pegunigalsidase-alfa-wins-chmp-backing-for-extended-dosing","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=56027","title":{"rendered":"Chiesi Fabry Drug Pegunigalsidase Alfa Wins CHMP Backing for Extended Dosing"},"content":{"rendered":"\n<p><strong>Chiesi Group<\/strong> announced that the <strong>Committee for Medicinal Products for Human Use (CHMP)<\/strong> has recommended approval for <strong>pegunigalsidase alfa<\/strong> using a <strong>2\u202fmg\/kg every\u2011four\u2011weeks (E4W)<\/strong> dosing regimen for adult Fabry disease patients stable on enzyme replacement therapy (ERT). The extended interval builds on the biweekly regimen approved by the European Commission in <strong>May\u202f2023<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone-amp-partnership-terms\">Regulatory Milestone &amp; Partnership Terms<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Chiesi Group \/ Chiesi Global Rare Diseases<\/td><\/tr><tr><td><strong>Co\u2011Developer<\/strong><\/td><td>Protalix BioTherapeutics (<a href=\"https:\/\/www.google.com\/finance\/quote\/PLX:NYSEAMERICAN\">NYSE: PLX<\/a>)<\/td><\/tr><tr><td><strong>Drug<\/strong><\/td><td>Pegunigalsidase alfa (pegylated ERT)<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Fabry disease<\/td><\/tr><tr><td><strong>CHMP Recommendation<\/strong><\/td><td>E4W dosing regimen (2\u202fmg\/kg)<\/td><\/tr><tr><td><strong>Previous Approval<\/strong><\/td><td>Biweekly regimen (May\u202f2023)<\/td><\/tr><tr><td><strong>Regulatory Milestone<\/strong><\/td><td>Protalix eligible for <strong>USD\u202f25\u202fmillion<\/strong> payment upon EC approval<\/td><\/tr><tr><td><strong>Strategic Value<\/strong><\/td><td>First ERT with flexible dosing options for Fabry patients<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-drug-profile-amp-clinical-innovation\">Drug Profile &amp; Clinical Innovation<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism:<\/strong> Pegylated enzyme replacement therapy delivering <strong>\u03b1\u2011galactosidase A<\/strong> to clear globotriaosylceramide (GL\u20113) accumulation<\/li>\n\n\n\n<li><strong>Dosing Advantage:<\/strong> E4W regimen reduces injection burden from <strong>26 to 13 infusions annually<\/strong>, improving patient compliance and quality of life<\/li>\n\n\n\n<li><strong>Patient Population:<\/strong> Targets adult Fabry patients <strong>stable on ERT<\/strong>, representing <strong>~60%<\/strong> of diagnosed population in EU<\/li>\n\n\n\n<li><strong>Competitive Landscape:<\/strong> Competes with Sanofi\u2019s Fabrazyme (biweekly) and Takeda&#8217;s Replagal (EOW); pegunigalsidase alfa\u2019s E4W option offers differentiation<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-impact-amp-commercial-outlook\">Market Impact &amp; Commercial Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Fabry Disease Market:<\/strong> EU market valued at <strong>$800\u202fmillion<\/strong> : in 2025, growing at <strong>6% CAGR<\/strong> ; limited treatment options create premium pricing opportunity<\/li>\n\n\n\n<li><strong>Milestone Impact:<\/strong> $25\u202fmillion payment to Protalix will support its <strong>protein expression platform<\/strong> development and pipeline advancement<\/li>\n\n\n\n<li><strong>Pricing Strategy:<\/strong> E4W convenience may support <strong>15\u201320% premium<\/strong> over standard biweekly ERTs<\/li>\n\n\n\n<li><strong>Strategic Validation:<\/strong> CHMP backing strengthens Chiesi\u2019s rare disease franchise and validates Protalix\u2019s <strong>plant\u2011cell expression technology<\/strong><\/li>\n\n\n\n<li><strong>Next Steps:<\/strong> European Commission decision expected <strong>Q2\u202f2026<\/strong>; US FDA filing for E4W regimen under discussion<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory approval timelines, milestone payments, and commercial prospects for pegunigalsidase alfa. Actual results may differ due to EC review outcomes, competitive dynamics, and market access negotiations.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chiesi Group announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended&#8230;<\/p>\n","protected":false},"author":1,"featured_media":56030,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[1919,4587,4586,24],"class_list":["post-56027","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-chiesi-farmaceutici","tag-nyse-plx","tag-protalix-biotherapeutics","tag-rare-orphan-disease-drugs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Chiesi Fabry Drug Pegunigalsidase Alfa Wins CHMP Backing for Extended Dosing - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Chiesi Group announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval for pegunigalsidase alfa using a 2\u202fmg\/kg every\u2011four\u2011weeks (E4W) dosing regimen for adult Fabry disease patients stable on enzyme replacement therapy (ERT). 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