{"id":47409,"date":"2022-08-17T21:01:44","date_gmt":"2022-08-17T19:01:44","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/bluebird-bio-announces-fda-approval-of-zynteglo-the-first-gene-therapy-for-people-with-beta-thalassemia-who-require-regular-red-blood-cell-transfusions\/"},"modified":"2022-08-17T21:01:44","modified_gmt":"2022-08-17T19:01:44","slug":"bluebird-bio-announces-fda-approval-of-zynteglo-the-first-gene-therapy-for-people-with-beta-thalassemia-who-require-regular-red-blood-cell-transfusions","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/bluebird-bio-announces-fda-approval-of-zynteglo-the-first-gene-therapy-for-people-with-beta-thalassemia-who-require-regular-red-blood-cell-transfusions\/","title":{"rendered":"bluebird bio Announces FDA Approval of ZYNTEGLO\u00ae, the First Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions"},"content":{"rendered":"
\n

\nZYNTEGLO offers potentially curative benefit across ages and genotypes, through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels<\/i>\n<\/p>\n

\nManagement team to host conference call Thursday, August 18 at 8:00 am ET<\/i>\n<\/p>\n

SOMERVILLE, Mass.–(BUSINESS WIRE)–bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO\u00ae<\/sup> (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta\u2011thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.\n<\/p>\n

<\/a><\/p>\n

\n\u201cThe FDA approval of ZYNTEGLO offers people with beta-thalassemia the possibility of freedom from burdensome regular red blood cell transfusions and iron chelation, and unlocks new possibilities in their daily lives,\u201d said Andrew Obenshain, chief executive officer, bluebird bio. \u201cAfter more than a decade of research and clinical development, and through the perseverance of clinicians, patients, and their families, the approval of ZYNTEGLO marks a watershed moment for the field of gene therapy. As the first ex-vivo<\/i> lentiviral vector gene therapy approved in the U.S. for the treatment of people with beta-thalassemia, we are ushering in a new era in which gene therapy has the potential to transform existing treatment paradigms for diseases that currently carry a lifelong burden of care.\u201d\n<\/p>\n

\nBeta-thalassemia is a rare, genetic blood disease caused by mutations in the beta-globin gene and characterized by significantly reduced or absent adult hemoglobin production. Patients with the most severe form, sometimes called transfusion-dependent beta-thalassemia or beta-thalassemia major, experience severe anemia and lifelong dependence on regular red blood cell transfusions, a lengthy process that patients typically undergo every 2-5 weeks. Despite advances in treatment and improved transfusion techniques, transfusions only temporarily address symptoms of anemia and people with beta\u2011thalassemia who require regular transfusions have an increased risk for morbidity and mortality due to complications from treatment-related iron overload. Data from the Cooley\u2019s Anemia Foundation indicate that the median age of death of patients with transfusion-dependent beta\u2011thalassemia in the U.S. who died during the last decade was just 37 years. bluebird estimates that there are approximately 1,300-1,500 individuals with transfusion-dependent beta-thalassemia in the U.S.\n<\/p>\n

\n\u201cTransfusion-dependent beta-thalassemia is associated with an intense treatment burden and significant health risks related to regular red blood transfusions and iron management,\u201d said Alexis A. Thompson, MD, MPH, Chief of the Division of Hematology, Children’s Hospital of Philadelphia. \u201cAs a clinician and an investigator in the ZYNTEGLO clinical development program, I celebrate the therapeutic potential of this treatment for patients and its implications for the field of gene therapy, all made possible through the incredible courage of patients and families who participated in the clinical trials.\u201d\n<\/p>\n

\n\u201cThe Cooley\u2019s Anemia Foundation applauds the FDA\u2019s approval of ZYNTEGLO for people with beta\u2011thalassemia who require regular red blood cell transfusions. The availability of a one-time gene therapy which offers the possibility of transfusion independence opens up new and exciting opportunities for those who are medically eligible to receive this treatment option,\u201d said Craig Butler, National Executive Director, Cooley\u2019s Anemia Foundation. \u201cWhile advances in treatment have been of enormous benefit to those with beta-thalassemia, a potentially curative therapy may offer a true life-changing experience.\u201d\n<\/p>\n

\nThe approval of ZYNTEGLO is the culmination of nearly 10 years of clinical research of gene therapy in patients with transfusion-dependent beta-thalassemia. ZYNTEGLO works by adding functional copies of a modified form of the beta-globin gene (\u03b2A-T87Q-<\/sup>globin gene) into a patient\u2019s own hematopoietic (blood) stem cells (HSCs) to allow them to make normal to near normal levels of total hemoglobin without regular RBC transfusions. The functional beta-globin gene is added into a patient\u2019s cells outside of the body (ex-vivo<\/i>), and then infused into the patient. Though ZYNTEGLO is designed to be administered to the patient once, the treatment process is comprised of several steps that may take place over the course of several months.\n<\/p>\n

\nDue to the complex nature of gene therapy, ZYNTEGLO will be available exclusively at Qualified Treatment Centers (QTCs) which are carefully selected based on their expertise in relevant areas such as stem cell transplantation, cell and gene therapy, and beta-thalassemia; and receive specialized training to administer ZYNTEGLO. Information on bluebird\u2019s QTC network, as well as personalized support focused on the needs of each patient throughout their treatment journey and information on insurance coverage and access will be available through bluebird\u2019s patient support program, my bluebird support<\/i>. Patients can call 833-888-NEST (833-888-6378) for more information, and additional details will be available at mybluebirdsupport.com in the coming days.\n<\/p>\n

\nZYNTEGLO was reviewed under Priority Review, and the Company received a Priority Review voucher upon approval. ZYNTEGLO was previously granted Orphan Drug designation and Breakthrough Therapy designation.\n<\/p>\n

\nClinical Data Supporting Approval of ZYNTEGLO<\/b>\n<\/p>\n

\nbluebird bio has the longest and most robust clinical program in transfusion-dependent beta\u2011thalassemia (TDT) in the field of gene therapy. The approval of ZYNTEGLO is based on data from bluebird bio\u2019s Phase 3 studies HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up study LTF-303.\n<\/p>\n

\nThe single-arm, open-label, 24-month Phase 3 studies of ZYNTEGLO included 41 patients aged 4 to 34 years with both non-\u03b20\/\u03b20 and \u03b20\/\u03b20 genotypes, with longest follow up out to 4 years. Eighty-nine percent (32\/36) of evaluable patients across ages and genotypes achieved transfusion independence (TI), which is defined as no longer needing red blood cell transfusions for at least 12 months while maintaining a weighted average total hemoglobin of at least 9 g\/dL. Results in these patients were durable as of last follow-up.\n<\/p>\n

\nThe most common non-laboratory adverse reactions (\u226520%) were mucositis, febrile neutropenia, vomiting, pyrexia, alopecia, epistaxis, abdominal pain, musculoskeletal pain, cough, headache, diarrhea, rash, constipation, nausea, decreased appetite, pigmentation disorder, and pruritus. The most common Grade 3 or 4 laboratory abnormalities (>50%) include neutropenia, thrombocytopenia, leukopenia, anemia, and lymphopenia.\n<\/p>\n

\nEnrollment is complete and all patients have been treated in the Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies evaluating ZYNTEGLO. Follow-up in HGB-212 is ongoing. bluebird bio is also conducting a long-term follow-up study, LTF-303, to monitor safety and efficacy for patients with TDT who have participated in bluebird bio-sponsored clinical studies of lentiviral vector (LVV) gene therapy through 15 years post-treatment.\n<\/p>\n

\nAcross all studies, all patients who achieved transfusion independence have remained transfusion-free.\n<\/p>\n

\nInvestor Conference Call Information<\/b>\n<\/p>\n

\nbluebird bio will host a call for analysts and investors on Thursday, August 18, 2022, at 8:00 am ET. Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link https:\/\/register.vevent.com\/register\/BIf8d187c3d45b4919a79fdc98742f39da<\/a> to register online.\n<\/p>\n

\nThe live webcast of the call and slide deck may be accessed by visiting the \u201cEvents & Presentations\u201d page within the Investors & Media section of the bluebird website at http:\/\/investor.bluebirdbio.com<\/a>. A replay of the webcast will be available on the bluebird website for 90 days following the event.\n<\/p>\n

\nAbout ZYNTEGLO\u00ae (betibeglogene autotemcel) or beti-cel<\/b>\n<\/p>\n

\nZYNTEGLO is a first-in-class, one-time ex-vivo <\/i>LVV gene therapy approved for the treatment of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. ZYNTEGLO works by adding functional copies of a modified form of the beta-globin gene (\u03b2A-T87Q-<\/sup>globin gene) into a patient\u2019s own hematopoietic (blood) stem cells to enable the production of a modified functional adult hemoglobin (HbAT87Q<\/sup>). Once a patient has the \u03b2A-T87Q-<\/sup>globin gene, they have the potential to increase ZYNTEGLO-derived adult hemoglobin (HbAT87Q<\/sup>) and total hemoglobin to normal or near normal levels that can eliminate the need for regular RBC transfusions.\n<\/p>\n

\nIndication<\/b>\n<\/p>\n

\nZYNTEGLO is indicated for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.\n<\/p>\n

\nImportant Safety Information<\/b>\n<\/p>\n

\nDelayed Platelet Engraftment<\/b>\n<\/p>\n

\nDelayed platelet engraftment has been observed with ZYNTEGLO treatment. Bleeding risk is increased prior to platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia; 15% of patients had \u2265 Grade 3 decreased platelets on or after Day 100.\n<\/p>\n

\nPatients should be made aware of the risk of bleeding until platelet recovery has been achieved. Monitor patients for thrombocytopenia and bleeding according to standard guidelines. Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved. Perform blood cell count determination and other appropriate testing whenever clinical symptoms suggestive of bleeding arise.\n<\/p>\n

\nRisk of Neutrophil Engraftment Failure<\/b>\n<\/p>\n

\nThere is a potential risk of neutrophil engraftment failure after treatment with ZYNTEGLO. Neutrophil engraftment failure is defined as failure to achieve three consecutive absolute neutrophil counts (ANC) \u2265 500 cells\/microliter obtained on different days by Day 43 after infusion of ZYNTEGLO. Monitor neutrophil counts until engraftment has been achieved. If neutrophil engraftment failure occurs in a patient treated with ZYNTEGLO, provide rescue treatment with the back-up collection of CD34+ cells.\n<\/p>\n

\nRisk of Insertional Oncogenesis<\/b>\n<\/p>\n

\nThere is a potential risk of LVV mediated insertional oncogenesis after treatment with ZYNTEGLO.\n<\/p>\n

\nPatients treated with ZYNTEGLO may develop hematologic malignancies and should be monitored lifelong. Monitor for hematologic malignancies with a complete blood count (with differential) at Month 6 and Month 12 and then at least annually for at least 15 years after treatment with ZYNTEGLO, and integration site analysis at Months 6, 12, and as warranted.\n<\/p>\n

\nIn the event that a malignancy occurs, contact bluebird bio at 1 833-999-6378 for reporting and to obtain instructions on collection of samples for testing.\n<\/p>\n

\nHypersensitivity Reactions<\/b>\n<\/p>\n

\nAllergic reactions may occur with the infusion of ZYNTEGLO. The dimethyl sulfoxide (DMSO) in ZYNTEGLO may cause hypersensitivity reactions, including anaphylaxis.\n<\/p>\n

\nAnti-retroviral and Hydroxyurea Use<\/b>\n<\/p>\n

\nPatients should not take prophylactic HIV anti-retroviral medications or hydroxyurea for at least one month prior to mobilization, or for the expected duration for elimination of the medications, and until all cycles of apheresis are completed. If a patient requires anti-retrovirals for HIV prophylaxis, then confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells.\n<\/p>\n

\nInterference with Serology Testing<\/b>\n<\/p>\n

\nPatients who have received ZYNTEGLO are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a false-positive test for HIV. Therefore, patients who have received ZYNTEGLO should not be screened for HIV infection using a PCR\u2011based assay.\n<\/p>\n

\nAdverse Reactions<\/b>\n<\/p>\n

\nThe most common non-laboratory adverse reactions (\u226520%) were mucositis, febrile neutropenia, vomiting, pyrexia, alopecia, epistaxis, abdominal pain, musculoskeletal pain, cough, headache, diarrhea, rash, constipation, nausea, decreased appetite, pigmentation disorder, and pruritus. The most common Grade 3 or 4 laboratory abnormalities (>50%) include neutropenia, thrombocytopenia, leukopenia, anemia, and lymphopenia.\n<\/p>\n

\nDrug Interactions<\/b>\n<\/p>\n

\nDrug-drug interactions between iron chelators and the myeloablative conditioning agent must be considered. Iron chelators should be discontinued at least 7 days prior to initiation of conditioning. The prescribing information for the iron chelator(s) and the myeloablative conditioning agent should be consulted for the recommendations regarding co-administration with CYP3A substrates.\n<\/p>\n

\nSome iron chelators are myelosuppressive. After ZYNTEGLO infusion, avoid use of these iron chelators for 6 months. If iron chelation is needed, consider administration of non-myelosuppressive iron chelators. Phlebotomy can be used in lieu of iron chelation, when appropriate.\n<\/p>\n

\nPregnancy\/Lactation<\/b>\n<\/p>\n

\nAdvise patients of the risks associated with conditioning agents, including on pregnancy and fertility.\n<\/p>\n

\nZYNTEGLO should not be administered to women who are pregnant, and pregnancy after ZYNTEGLO infusion should be discussed with the treating physician.\n<\/p>\n

\nZYNTEGLO is not recommended for women who are breastfeeding, and breastfeeding after ZYNTEGLO infusion should be discussed with the treating physician.\n<\/p>\n

\nFemales and Males of Reproductive Potential<\/b>\n<\/p>\n

\nA negative serum pregnancy test must be confirmed prior to the start of mobilization and re-confirmed prior to conditioning procedures and before ZYNTEGLO administration.\n<\/p>\n

\nWomen of childbearing potential and men capable of fathering a child should use an effective method of contraception (intra uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of ZYNTEGLO.\n<\/p>\n

\nAdvise patients of the option to cryopreserve semen or ova before treatment if appropriate.\n<\/p>\n

\nPlease see full Prescribing Information<\/a> for ZYNTEGLO.\n<\/p>\n

\nAbout bluebird bio, Inc.<\/b>\n<\/p>\n

\nbluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days. With a dedicated focus on severe genetic diseases, bluebird has industry-leading clinical and research programs for sickle cell disease, beta-thalassemia and cerebral adrenoleukodystrophy and is advancing research to apply new technologies to these and other diseases. We custom design each of our therapies to address the underlying cause of disease <\/sup>and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.\n<\/p>\n

\nFounded in 2010, bluebird has the largest and deepest ex-vivo<\/i> gene therapy data set in the world\u2014setting the standard for industry. Today, bluebird continues to forge new paths, combining our real\u2011world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds. \u200b\n<\/p>\n

\nFor more information, visit bluebirdbio.com<\/b><\/a> or follow us on social media at @bluebirdbio<\/b><\/a>, LinkedIn<\/b><\/a>, Instagram<\/b><\/a> and YouTube<\/b><\/a>.\n<\/p>\n

\nZYNTEGLO and bluebird bio are trademarks of bluebird bio, Inc.\n<\/p>\n

\nbluebird bio Cautionary Statement Regarding Forward-Looking Statements<\/b>\n<\/p>\n

\nThis press release contains \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio\u2019s business, particularly those identified in the risk factors discussion in bluebird bio\u2019s Annual Report on Form 10-K, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. These risks and uncertainties include, but are not limited to: the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be seen in the commercial treatment context; the risk that additional insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation will be discovered or reported over time; the risk that we may not be able to obtain adequate price and reimbursement for any approved products; the risk that we may encounter delays in the initiation of our commercial operations in the United States; and the risk that any one or more of our product candidates will not be successfully developed, approved by the FDA or commercialized. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nInvestors:<\/b>
Courtney O\u2019Leary, 978-621-7347
\n
coleary@bluebirdbio.com<\/b><\/a><\/p>\n

Media:<\/b>
Jess Rowlands, 857-299-6103
\n
jess.rowlands@bluebirdbio.com<\/b><\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

ZYNTEGLO offers potentially curative benefit across ages and genotypes, through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels Management team to host conference call Thursday, August 18 at 8:00 am ET SOMERVILLE, Mass.–(BUSINESS WIRE)–bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47409","6":"format-standard","7":"category-industry"},"yoast_head":"\nbluebird bio Announces FDA Approval of ZYNTEGLO\u00ae, the First Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/bluebird-bio-announces-fda-approval-of-zynteglo-the-first-gene-therapy-for-people-with-beta-thalassemia-who-require-regular-red-blood-cell-transfusions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"bluebird bio Announces FDA Approval of ZYNTEGLO\u00ae, the First Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"ZYNTEGLO offers potentially curative benefit across ages and genotypes, through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels Management team to host conference call Thursday, August 18 at 8:00 am ET SOMERVILLE, Mass.–(BUSINESS WIRE)–bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved ... 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(Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved ... 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