New Analyses from the Phase 3 HELP Study™ Open-Label Extension in Hereditary Angioedema Evaluate Efficacy and Safety of TAKHZYRO® (lanadelumab-flyo) Injection During Extended Study Treatment Period
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced new data that further investigates the long-term safety and efficacy of TAKHZYRO ® (lanadelumab-flyo) injection in patients with hereditary angioedema (HAE) 12 years of age and older studied in the ongoing Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE). The analyses, being presented at the 2019 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting in Houston, Texas from November 7-11, showed that TAKHZYRO continued to prevent HAE attacks at a rate similar to that observed in the pivotal HELP Study, in patients who received treatment for a mean duration of 19.7 (0-26.1) months.1, 2 The analyses will also be published in the November issue of ACAAI’s journal Annals of Allergy, Asthma & Immunology.
The original Phase 3 HELP Study was conducted in 125 patients over 26 weeks making it the largest randomised, controlled prevention study in HAE, with the longest active treatment duration, to date.3 The ongoing HELP Study OLE is designed to evaluate the long-term safety (primary endpoint) and efficacy of TAKHZYRO and is expected to be completed in November 2019. These analyses included 109 rollover patients, who were originally evaluated in the HELP Study, and 103 eligible non-rollover patients who did not participate in the initial study but had experienced at least one attack in 12 weeks.1, 2, 4
Results from the HELP Study OLE showed that the safety profile of TAKHZYRO was consistent with the original findings from the HELP Study, with treatment-related treatment emergent adverse events (TEAEs) occurring in 50% of patients (n=106).2 In addition, TAKHZYRO 300 mg every 2 weeks reduced the rate of attacks, attacks requiring acute treatment, and moderate to severe attacks (secondary efficacy endpoints). The mean attack rate was reduced by 87% overall compared with baseline (N=212). Similarly there was an overall reduction of 92.6% in the rate of attacks requiring acute treatment (N=212) and 83.6% in the rate of moderate/severe attacks versus baseline (N=212).1 An exploratory analysis showed that the overall maximum attack-free period lasted ≥12 months in 58% of patients (n=209) and ≥6 months in 78% of patients (n=209) following the first regular treatment dose.1
“While the original HELP Study data has given us a strong understanding of how TAKHZYRO can prevent HAE attacks, the results of these analyses provide encouraging insight into its potential safety and efficacy over a longer duration,” said Marc A. Riedl, M.D., investigator in the HELP Study OLE and Professor of Medicine and Clinical Director, U.S. Hereditary Angioedema Association Center at the University of California, San Diego. “As HAE is a lifelong condition, the long-term efficacy and safety of prophylactic medications are important factors in developing individualized HAE management plans. The HELP Study OLE analyses are a positive step forward in understanding the long-term effects of TAKHZYRO, and we look forward to gathering and sharing additional data as the study progresses.”
In the study, TEAEs occurred in ~95% of patients (N=212) and were mostly mild or moderate in severity. The TEAEs related to treatment that were reported in more than 5% of patients are injection site pain (33.9% of rollover patients [n=37] and 42.7% of non-rollover patients [n=44]), injection site erythema (11.9% of rollover patients [n=13] and 15.5% of non-rollover patients [n=16]) and injection site bruising (4.6% of rollover patients [n=5] and 9.7% of non-rollover patients [n=10]).2
TEAEs of special interest were reported in eight (3.8%) patients; none were serious. Six (2.8%) patients discontinued from the study due to TEAEs, one of which was treatment related (injection site papules). No treatment related, serious TEAEs or deaths occurred. Anti-lanadelumab antibodies were detected in 21 (9.9%) patients, including six (2.8%) positive for neutralizing antibodies with no discernible clinical impact.2
“Recurrent and unpredictable attacks of swelling can be debilitating and impact those living with HAE in a number of ways,” said Donatello Crocetta, M.D., Global Medical Head, Rare Immunology Franchise, Chief Medical Office, Takeda. “Over the last 10 years, we have been committed to continuous innovation in HAE to help address patients’ unmet treatment needs. These findings build on our knowledge about HAE and are valuable in better understanding the benefits that preventive treatment with TAKHZYRO could bring to patients in the longer term.”
Details on the HELP Study OLE abstracts being presented are as follows:
Long-Term Efficacy of Lanadelumab: Interim Results from the HELP OLE Study Abstract #P1591
- Friday, 8 November, 5:15-5:30pm
Long-Term Safety of Lanadelumab in Hereditary Angioedema (HAE): Interim Results From the HELP OLE Study Abstract #P1582
- Friday, 8 November, 5:00-5:15pm
Long-Term Lanadelumab Treatment Improves Health-related Quality of Life: HELP OLE Study Interim Findings Abstract #P1564
- Friday, 8 November, 4:30-4:45pm
About The HELP Study™ Open-label Extension
The HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE) is an evaluation of the long-term efficacy and safety of TAKHZYRO in hereditary angioedema (HAE) patients of at least 12 years of age and older. Two hundred and twelve patients received treatment with TAKHZYRO at the start of the OLE Study (109 rollover patients originally evaluated in the HELP Study and who continued into the OLE, and 103 eligible patients who did not participate in the HELP study but who had experienced at least one attack in 12 weeks). Rollover patients received a dose of 300 mg TAKHZYRO on Day 0 and then every two weeks after their first attack. Non-rollover patients were treated with one 300 mg dose every two weeks, beginning on Day 0. One hundred and ninety-three participants completed at least 12 months of treatment and 27 participants completed at least 24 months of treatment.1, 2
About Hereditary Angioedema
Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.5, 6, 7 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.6, 7 HAE affects an estimated 1 in 10,000 to 1 in 50,000 people worldwide. It is often under-recognized, under-diagnosed and under-treated.5, 8
About TAKHZYRO® (lanadelumab-flyo) Injection
TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for prophylaxis to prevent HAE attacks in patients 12 years and older. TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks.9 TAKHZYRO is intended for self-administration or administration by a caregiver. The patient or caregiver should be trained by a healthcare professional.9
U.S. Indication and Important Safety Information
TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.9
IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.9
Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.9
Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.9
No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.9
To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-828-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For U.S. audiences, please see the full Prescribing Information including Medication Guide for TAKHZYRO®.
For EU audiences, please see the Summary of Product Characteristics (SmPC) for TAKHZYRO®.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
For more information, visit https://www.takeda.com.
1 Riedl MA, Cicardi M, Hao J, et al; for the HELP OLE Study Investigators. Long-Term Efficacy of Lanadelumab: Interim Results from the HELP Open-Label Study. ACAAI 2019. Abstract #P159.
2 Johnston DT, Banerji A, Nurse C, et al; for the HELP OLE Study Investigators. Long-Term Safety of Lanadelumab in Hereditary Angioedema (HAE): Interim Results From the HELP OLE Study. ACAAI 2019. Abstract #P158.
3 Banerji A, Riedl MA, Bernstein JA, et al; for the HELP Investigators. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121.
4 Lumry WR, Maurer M, Megerl M, et al; for the HELP OLE Study Investigators. Long-term Lanadelumab Treatment Improves Health-related Quality of Life: HELP Open-label Extension Study Interim Findings. ACAAI 2019. Abstract #P156.
5 Cicardi M, Bork K, Caballero T, et al; on behalf of HAWK (Hereditary Angioedema International Working Group). Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012; 67(2):147-157.
6 Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
7 Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.
8 Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.
9 TAKHZYRO ® (lanadelumab) Summary of Product Characteristics.
+81 (0) 3-3278-2095
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Data Security Innovator, Secure Channels, Chooses Thales to Provide Key Management and Software Licensing Platform For IoT Security Solution22.1.2020 10:00:00 EET | Press release
Thales has announced its encryption key management and software licencing platforms have been chosen by Secure Channels to protect its quantum-resilient encryption keys for its IoT-enabled devices. By using Thales’ key management platform, both companies’ customers will benefit from increased data protection no matter the connected device, even if there is no current security protection in place. In addition, Thales’ software licensing platform will enable easy access to Secure Channels’ cybersecurity software technology for customers and manufacturers, thus ensuring all IoT devices can be protected easily either at source or retrospectively. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200121005189/en/ (Photo: Thales) “Thales’s Sentinel Entitlement Management Software has enabled the first generation of truly secure connected devices,” said Secure Channels Chief Executive Officer Richard Blech. “With the vast increase in
Jefferies to Hold Asia Pacific Trading Day in Support of Australia Wildfires Relief Today, January 2222.1.2020 10:00:00 EET | Press release
Jefferies announced that today is the firm’s trading day to support relief efforts caused by the recent wildfires in Australia. Jefferies will offer investors the opportunity to join efforts to assist those affected by the devastation of this event by trading with Jefferies. As previously announced, Jefferies will donate net trading commissions from today, Wednesday, January 22 for all trading in Asia Pacific securities, including equities, fixed income and FX, by the firm’s clients globally. Simultaneously, all of the firm’s global employees will also be given the opportunity to personally donate to the relief effort. Jefferies will match all client trading commissions generated today, as well as match all employee donations from across the firm. The total contribution will then be donated to relief organizations directly involved in the rescue and recovery efforts in Australia. Rich Handler, CEO, and Brian Friedman, President, of Jefferies commented: "All of us at Jefferies, includin
Naspers Limited: Results of the Sale by Naspers Limited of 22 Million N Ordinary Shares of Prosus N.V. Through an Accelerated Bookbuild Offering to Institutional Investors22.1.2020 09:30:00 EET | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH OFFERS OR SALES WOULD BE PROHIBITED BY APPLICABLE LAWs and REgulations. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE IN ANY JURISDICTION, INCLUDING THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN. NEITHER THIS ANNOUNCEMENT NOR ANYTHING CONTAINED HEREIN SHALL FORM THE BASIS OF, OR BE RELIED UPON IN CONNECTION WITH, ANY OFFER OR COMMITMENT WHATSOEVER IN ANY JURISDICTION. Naspers Limited (JSE: NPN; LSE: NPSN) ("Naspers") has sold 22 million N ordinary shares (the "Prosus N Ordinary Shares") in Prosus N.V. ("Prosus"), corresponding to c. 1.4% of the issued Prosus N Ordinary Shares, at a price per Prosus N Ordinary Share of €67.50, resulting in gross proceeds of approximately €1.5 billion for Naspers. The sale was effected through an accelerated bookbuild offering to institutional investors (the "Placin
CollabNet VersionOne and XebiaLabs Combine to Create Integrated Agile DevOps Platform22.1.2020 05:10:00 EET | Press release
CollabNet VersionOne (CollabNet), a leading provider for Agile planning and collaborative development, and XebiaLabs, the leader in release orchestration, deployment, and continuous delivery, announced today that the two companies have merged. The combination, which was backed by TPG Capital, unites CollabNet’s upstream Agile planning and enterprise version control functionality with XebiaLabs’ downstream release orchestration and deployment automation capabilities to create an Agile, end-to-end, DevOps platform for enterprises. In connection with the transaction, Ashok Reddy, an accomplished industry veteran and former Broadcom executive, has joined the combined company as CEO. He replaces Flint Brenton, who is stepping aside to focus on family and personal interests after nearly five years of successful stewardship. Derek Langone, current CEO of XebiaLabs, will serve as President of the combined company. Stephen Gregorio, EVP and CFO of XebiaLabs, will serve as the combined company’s
Gilead Sciences to Release Fourth Quarter and Full Year 2019 Financial Results on Tuesday, February 4, 202022.1.2020 01:30:00 EET | Press release
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2019 financial results will be released on Tuesday, February 4, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s fourth quarter and full year 2019 financial results and will provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 9634129 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, February 6, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (intern
Bermuda Further Enhances Its International Appeal as Incorporated Segregated Accounts Companies Legislation Comes Into Effect22.1.2020 01:10:00 EET | Press release
Bermuda’s Incorporated Segregated Accounts Companies Act 2019 (ISAC Act) came into effect on January 15, 2020, providing multiple industries with yet another compelling reason for choosing to domicile their business on island. The ISAC Act, a stand-alone piece of legislation and a companion statute to the Segregated Accounts Companies Act 2000, further enhances Bermuda’s legislative framework by introducing a new and innovative company structure to cater to the needs of existing and prospective businesses. ISACs enable the creation of corporate group structures to operate multiple businesses or ‘accounts’, each ring-fenced with its own separate legal identity, under one umbrella. As such, each account has the capacity, rights, powers and privileges of a natural person, including the right to enter into contracts with other accounts under the ISAC and with the ISAC itself. There are no limits on the number of accounts an ISAC may establish. This structure not only offers greater flexibi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom