{"id":31401,"date":"2025-04-01T18:02:40","date_gmt":"2025-04-01T12:32:40","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=31401"},"modified":"2025-04-01T18:03:37","modified_gmt":"2025-04-01T12:33:37","slug":"pharma-news-for-beam-astrazeneca-sanofi","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi","title":{"rendered":"Sanofi\u2019s Qfitlia Becomes First FDA-Approved Therapy for Hemophilia A or B; FDA Approves AstraZeneca\u2019s IMFINZI as First Perioperative Immunotherapy for Bladder Cancer; Beam Therapeutics&#8217; BEAM-302 for AATD Receives FDA Clearance; AstraZeneca\u2019s CALQUENCE Combo Greenlit in EU for Mantle Cell Lymphoma; Ionis\u2019 WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a1748131b9b4\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a1748131b9b4\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi\/#Sanofis_Qfitlia_Becomes_First_US-Approved_Therapy_for_Hemophilia_A_or_B\" >Sanofi\u2019s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi\/#AstraZenecas_IMFINZI_Approved_in_US_as_First_Perioperative_Immunotherapy_for_Bladder_Cancer\" >AstraZeneca\u2019s IMFINZI Approved in US as First Perioperative Immunotherapy for Bladder Cancer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi\/#Beam_Therapeutics_Gains_FDA_Clearance_for_BEAM-302_IND_in_AATD\" >Beam Therapeutics Gains FDA Clearance for BEAM-302 IND in AATD<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi\/#AstraZenecas_CALQUENCE_Recommended_for_EU_Approval_as_First_BTK_Inhibitor_for_Mantle_Cell_Lymphoma\" >AstraZeneca&#8217;s CALQUENCE Recommended for EU Approval as First BTK Inhibitor for Mantle Cell Lymphoma<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi\/#Ionis_WAINZUA_Wins_EU_Approval_for_Hereditary_Transthyretin_Amyloidosis\" >Ionis&#8217; WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-sanofi-s-qfitlia-becomes-first-us-approved-therapy-for-hemophilia-a-or-b\"><span class=\"ez-toc-section\" id=\"Sanofis_Qfitlia_Becomes_First_US-Approved_Therapy_for_Hemophilia_A_or_B\"><\/span>Sanofi\u2019s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>FDA has approved Qfitlia (fitusiran)<\/strong>, the first <strong>antithrombin-lowering therapy<\/strong> for routine prophylaxis to prevent or reduce bleeding episodes in <a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-a2030-market\"><strong>hemophilia A<\/strong><\/a><strong> or <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-market\"><strong>hemophilia B<\/strong><\/a> patients (ages 12+) with or without inhibitors. Approval is based on <strong>ATLAS Phase III trials<\/strong>, which showed a <strong>71% reduction in annualized bleeding rates (ABR) for patients without inhibitors<\/strong> and a <strong>73% reduction for those with inhibitors<\/strong>. Qfitlia uses small-interfering RNA technology, allowing low-frequency, subcutaneous dosing.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cCurrent treatment options force trade-offs between bleed control and convenience,\u201d said Phil Gattone, President and CEO, National Bleeding Disorders Foundation. \u201cQfitlia offers a novel approach, providing effective bleed protection while reducing dosing frequency.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>By lowering <strong>antithrombin (AT)<\/strong>\u2014a protein that inhibits clotting\u2014Qfitlia increases <strong>thrombin generation<\/strong> to restore hemostasis. It offers the <strong>fewest doses of any prophylactic hemophilia therapy<\/strong>, with as few as six injections per year. The <strong>FDA also cleared Siemens Healthineers\u2019 INNOVANCE Antithrombin assay<\/strong> as a companion diagnostic to measure AT levels in patients prescribed Qfitlia. Sanofi is launching HemAssist, a support program for patients, covering financial assistance, insurance support, and education.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval underscores our commitment to innovation in rare blood disorders,\u201d said Brian Foard, Executive VP, Head of Specialty Care, Sanofi. \u201cQfitlia can reshape the hemophilia landscape with its effective bleed protection, infrequent dosing, and simplified administration.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Qfitlia comes with potential risks, including thrombotic events, gallbladder disease, and hepatotoxicity. The FDA granted Orphan Drug, Fast Track, and Breakthrough Therapy designations for hemophilia treatment. Regulatory submissions are under review in Brazil and China, with a decision in China expected in late 2025.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-astrazeneca-s-imfinzi-approved-in-us-as-first-perioperative-immunotherapy-for-bladder-cancer\"><span class=\"ez-toc-section\" id=\"AstraZenecas_IMFINZI_Approved_in_US_as_First_Perioperative_Immunotherapy_for_Bladder_Cancer\"><\/span>AstraZeneca\u2019s IMFINZI Approved in US as First Perioperative Immunotherapy for Bladder Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>FDA has approved AstraZeneca\u2019s IMFINZI (durvalumab) in combination with chemotherapy<\/strong> as the first <a href=\"https:\/\/www.delveinsight.com\/report-store\/muscle-invasive-bladder-cancer-market\"><strong>perioperative immunotherapy for muscle-invasive bladder cancer (MIBC)<\/strong><\/a>. The approval, granted after Priority Review, is based on <strong>NIAGARA Phase III trial results<\/strong>, which showed a <strong>32% reduction in recurrence risk<\/strong> and a <strong>25% reduction in death risk<\/strong> compared to neoadjuvant chemotherapy alone. The trial, presented at <strong>ESMO 2024<\/strong> and published in The New England Journal of Medicine, highlighted the urgent need for better treatment options, as nearly half of MIBC patients experience disease recurrence despite standard chemotherapy and surgery.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval is a major breakthrough for MIBC patients, significantly extending lives in the NIAGARA trial,\u201d said Dr. Matthew Galsky of Mount Sinai. \u201cThe regimen has the potential to transform care.\u201d Dave Fredrickson, AstraZeneca\u2019s EVP of Oncology, added, \u201cIMFINZI represents a paradigm shift, bringing the first perioperative immunotherapy to MIBC patients and addressing a significant unmet need.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The NIAGARA trial demonstrated that 67.8% of patients treated with the IMFINZI regimen were event-free at two years, compared to 59.8% in the comparator group. Additionally, 82.2% of patients receiving IMFINZI were alive at two years, versus 75.2% in the control arm. The treatment was generally well tolerated, with no new safety concerns. In February 2025, the NCCN Clinical Guidelines added IMFINZI\u2019s perioperative regimen as a Category 1 Recommended treatment for MIBC.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThere is a critical need for better treatments in MIBC,\u201d said Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network. \u201cThe approval of this regimen is a game-changer for patients and their families.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>IMFINZI is also <strong>approved <\/strong>in <strong>Brazil <\/strong>for this setting, with regulatory reviews ongoing in the EU, Japan, and other countries.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-beam-therapeutics-gains-fda-clearance-for-beam-302-ind-in-aatd\"><span class=\"ez-toc-section\" id=\"Beam_Therapeutics_Gains_FDA_Clearance_for_BEAM-302_IND_in_AATD\"><\/span>Beam Therapeutics Gains FDA Clearance for BEAM-302 IND in AATD<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Beam Therapeutics announced that the <strong>FDA has cleared the IND application for BEAM-302<\/strong>, a <strong>precision genetic medicine for <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/alpha-1-antitrypsin-deficiency-a1atd-market\"><strong>alpha-1 antitrypsin deficiency (AATD)<\/strong><\/a>. BEAM-302, a <strong>liver-targeting base editing therapy<\/strong>, aims to correct the <strong>PiZ mutation<\/strong>, which causes AATD-related lung and liver disease. There are currently <strong><em>no approved curative treatments<\/em><\/strong> for AATD.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis clearance is a critical step toward delivering a potential breakthrough for AATD patients in the U.S.,\u201d said Giuseppe Ciaramella, Ph.D., President of Beam. \u201cOur initial Phase I\/II data demonstrated the first-ever clinical genetic correction of a disease-causing mutation, and we are focused on advancing enrollment and expanding trial sites.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>BEAM-302 is currently being tested in a Phase I\/II clinical trial assessing its safety, tolerability, pharmacokinetics, and efficacy. The trial consists of Part A (AATD patients with lung disease) and Part B (patients with mild to moderate liver disease, with or without lung disease). The therapy has also received clinical trial authorization in the UK, Australia, New Zealand, the Netherlands, and Ireland.<\/p>\n\n\n\n<p>Beam plans to continue dose escalation in Part A and expects to present updated data in late 2025. The company will also initiate dosing in Part B later this year, marking a major step toward establishing BEAM-302 as a one-time genetic treatment for AATD.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-astrazeneca-s-calquence-recommended-for-eu-approval-as-first-btk-inhibitor-for-mantle-cell-lymphoma\"><span class=\"ez-toc-section\" id=\"AstraZenecas_CALQUENCE_Recommended_for_EU_Approval_as_First_BTK_Inhibitor_for_Mantle_Cell_Lymphoma\"><\/span>AstraZeneca&#8217;s CALQUENCE Recommended for EU Approval as First BTK Inhibitor for Mantle Cell Lymphoma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>AstraZeneca\u2019s <strong>CALQUENCE (acalabrutinib) plus bendamustine and rituximab<\/strong> has been <strong>recommended for EU approval<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/mantle-cell-lymphoma-market\"><strong>previously untreated mantle cell lymphoma (MCL)<\/strong><\/a> in adults <strong>ineligible for stem cell transplantation<\/strong>. The CHMP\u2019s positive opinion is based on the ECHO Phase III trial, which showed a 27% reduction in disease progression or death vs. chemoimmunotherapy alone.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe ECHO trial demonstrated the significant benefits of the CALQUENCE combination in managing this rare and aggressive cancer,\u201d said Dr. Martin Dreyling of University Hospital LMU Munich. \u201cThis recommendation is a major step for older MCL patients needing both efficacy and tolerability.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>CALQUENCE plus bendamustine and rituximab has already been <strong>approved in the US and other countries<\/strong>, with regulatory reviews ongoing in <strong>Japan and several other regions<\/strong>. The CHMP also recently <strong>recommended CALQUENCE monotherapy<\/strong> for <strong>relapsed or refractory MCL<\/strong>, reinforcing its potential to <strong>reshape the standard of care<\/strong>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cIf approved, CALQUENCE would be the first BTK inhibitor for 1L MCL in Europe, offering patients a significant PFS advantage,\u201d said Susan Galbraith, EVP, Oncology R&amp;D at AstraZeneca. \u201cThis marks a critical advancement in treatment options.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-ionis-wainzua-wins-eu-approval-for-hereditary-transthyretin-amyloidosis\"><span class=\"ez-toc-section\" id=\"Ionis_WAINZUA_Wins_EU_Approval_for_Hereditary_Transthyretin_Amyloidosis\"><\/span>Ionis&#8217; WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Ionis Pharmaceuticals and AstraZeneca<\/strong> have received <strong>European Union (EU) approval for WAINZUA (eplontersen)<\/strong>, a <strong>once-monthly RNA-targeted therapy<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/hereditary-transthyretin-amyloidosis-competitive-landscape-and-market\"><strong>hereditary transthyretin-mediated amyloidosis with polyneuropathy (ATTRv-PN)<\/strong><\/a> in adult patients with <strong>stage 1 or stage 2 polyneuropathy<\/strong>. This makes WAINZUA the <strong>only approved ATTRv-PN treatment in the EU that can be self-administered via an auto-injector<\/strong>.<\/p>\n\n\n\n<p>The European Commission\u2019s (EC) decision, based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), was supported by data from the NEURO-TTRansform Phase III trial. Over 66 weeks, WAINZUA demonstrated sustained reduction in serum transthyretin (TTR) concentration, significant improvement in neuropathy impairment (measured by mNIS+7), and better quality of life outcomes compared to an external placebo. The therapy also showed a favorable safety and tolerability profile throughout the trial.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>Brett P. Monia, Ph.D., CEO of Ionis Pharmaceuticals<\/em><\/strong><em>, emphasized the impact of the approval, stating:<\/em><em><br><\/em><em> &#8220;Today\u2019s approval of WAINZUA in Europe offers adults with ATTRv-PN a new, self-administered treatment option that provides consistent suppression of transthyretin production and improves neuropathy impairment and quality of life. With approvals in North America, the UK, and now across the EU, we are proud of the continued progress as we and our partner, AstraZeneca, rapidly and effectively deliver WAINZUA to people around the world.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>ATTRv-PN is a debilitating genetic disorder that progressively damages peripheral nerves, leading to motor disability within five years and often proving fatal within a decade if left untreated. Current treatment options remain limited, making WAINZUA a significant advancement in disease management. WAINZUA aims to slow disease progression and improve patient outcomes by reducing TTR production at its source.<\/p>\n\n\n\n<p>Already approved in the U.S. (marketed as WAINUA), Canada, and the UK, WAINZUA continues to expand globally. As part of a joint development and commercialization agreement, AstraZeneca and Ionis are working on securing further regulatory approvals worldwide, with AstraZeneca holding exclusive commercialization and development rights outside the U.S.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sanofi\u2019s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B The FDA has approved Qfitlia (fitusiran), the first antithrombin-lowering therapy for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or hemophilia B patients (ages 12+) with or without inhibitors. Approval is based on ATLAS Phase III trials, which showed a 71% [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":31402,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[19857,16852,3987,2063,204,704,20287,283,284,285,349,19103,420,639,5789],"industry":[17225],"therapeutic_areas":[17238,17233,17228],"class_list":["post-31401","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alpha-1-antitrypsin-deficiency-market","tag-amyloidosis","tag-antitrypsin-deficiency","tag-bladder-cancer","tag-delveinsight","tag-fda","tag-hattr-amyloidosis","tag-hemophilia","tag-hemophilia-a","tag-hemophilia-b","tag-latest-pharma-news","tag-mantle-cell-lymphoma","tag-news","tag-pharma-news","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-genetic-disorders","therapeutic_areas-hematological-disorders","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharma News | Beam, AstraZeneca, Sanofi<\/title>\n<meta name=\"description\" content=\"Sanofi\u2019s Qfitlia Approved, AstraZeneca\u2019s IMFINZI, Beam\u2019s BEAM-302 FDA Clearance, AstraZeneca\u2019s CALQUENCE, Ionis\u2019 WAINZUA\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Beam, AstraZeneca, Sanofi\" \/>\n<meta property=\"og:description\" content=\"Sanofi\u2019s Qfitlia Approved, AstraZeneca\u2019s IMFINZI, Beam\u2019s BEAM-302 FDA Clearance, AstraZeneca\u2019s CALQUENCE, Ionis\u2019 WAINZUA\" 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content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jatin Vimal\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Pharma News | Beam, AstraZeneca, Sanofi","description":"Sanofi\u2019s Qfitlia Approved, AstraZeneca\u2019s IMFINZI, Beam\u2019s BEAM-302 FDA Clearance, AstraZeneca\u2019s CALQUENCE, Ionis\u2019 WAINZUA","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-beam-astrazeneca-sanofi","og_locale":"en_US","og_type":"article","og_title":"Pharma News | Beam, AstraZeneca, Sanofi","og_description":"Sanofi\u2019s Qfitlia 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