Fintech PR
Takeda Receives Positive CHMP Opinion Recommending Approval of Lanadelumab for Routine Prevention of Recurrent Attacks of Hereditary Angioedema (HAE) in Patients Aged 2 years and Older
- If Approved, Lanadelumab Will be the First Long-Term Prophylactic Treatment of HAE Available in the EU for Patients Under the Age of Six.
- Positive Opinion Based on Pivotal Study SHP643-301, Evaluating the Safety Profile and Pharmacokinetics (PK) of Lanadelumab, in Combination with Extrapolation of Data from the Pivotal Adult and Adolescent Study DX-2930-03.
- HAE is a Rare, Genetic Disorder Estimated to Affect About 1 in 10,000 to 1 in 50,000 People Worldwide. The Condition Results in Recurring Attacks of Oedema (Swelling) in Various Parts of the Body that can be Debilitating and Painful.[1],[2],[3]
ZURICH, Sept. 22, 2023 /PRNewswire/ — Takeda (TSE:4502) (NYSE:TAK) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of lanadelumab (trade name TAKHZYRO®) for the routine prevention of Hereditary Angioedema (HAE) in patients aged 2 years and older. If approved, lanadelumab will be the first long-term prophylactic treatment available in the EU for patients under the age of six.[4],[5],[6] The European Commission (EC) will consider the CHMP positive opinion and decide upon potential marketing authorization in the coming months. Lanadelumab is currently indicated for the routine prevention of recurrent attacks of HAE in patients aged 12 years and older.[7]
HAE attacks, which can involve serious and severely debilitating swelling in the abdomen, face, feet, genitals, hands and throat, may occur very early in childhood.[8] Potentially fatal upper airway angioedema has been reported in patients as young as 3 years old.[9] HAE diagnosis can take an average of 8.4 years after symptom onset.2
“We are so pleased to achieve this positive step towards providing the first long-term prophylactic treatment option to prevent attacks in this vulnerable population,” said Didier Relin, Head of International Regulatory at Takeda. “We know that HAE can be a complex, debilitating condition, and we are committed to being a champion for all individuals living with HAE.”
The positive opinion is supported by data from Phase 3 Study SHP643-301, also known as the SPRING study, a multicenter, open-label Phase 3 study to evaluate the safety profile and pharmacokinetics (PK) of lanadelumab in patients 2 to <12 years of age. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events and no dropouts due to adverse events. The study also successfully reached the secondary objective evaluating the clinical activity/outcome of lanadelumab in preventing hereditary angioedema (HAE) attacks as well as characterizing the pharmacokinetics of lanadelumab in paediatric patients 2 to <12 years of age.[10]
In February, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO® (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in paediatric patients 2 to <12 years of age.[11]
Notes to Editors
About HAE
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.1 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.2 HAE affects an estimated 1 in 50,000 people worldwide.3 It is often under recognized, under diagnosed and under treated.3
HAE, like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are bold in our mission to accelerate diagnosis and develop treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them.
About Lanadelumab (TAKHZYRO®)
Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 12 years and older. It was studied in one of the largest prevention studies in HAE with the longest active treatment duration, and Lanadelumab consistently demonstrated HAE attack reduction. Lanadelumab is formulated for subcutaneous administration and has a half-life of approximately two weeks. Lanadelumab is intended for self-administration or administration by a caregiver once trained by a healthcare professional.4
About Study SHP643-301 (SPRING Study)
SHP643-301 is A Multicenter, Open-Label Phase 3 Study to Evaluate Safety, PK, Pharmacodynamics, And Clinical Activity/Outcomes of TAKHZYRO for Prevention Against Acute Attacks of HAE in Pediatric Patients 2 To <12 Years of Age. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events and no dropouts due to adverse events. The study also successfully reached the secondary objective evaluating the clinical activity/outcome of TAKHZYRO in preventing hereditary angioedema (HAE) attacks as well as characterizing the pharmacodynamics of TAKHZYRO in paediatric patients 2 to <12 years of age.10
About Takeda Pharmaceutical Company
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). 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.
Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefings and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction.
References
[1] Maurer, M., Magerl, M., et al. (2022). The international WAO/EAACI guideline for the management of hereditary angioedema—The 2021 revision and update. Allergy, 77(7), 1961–1990. https://doi.org/10.1111/all.15214.
[2] Banerji, A., Davis, K. H., Brown, T. M., Hollis, K., Hunter, S. M., Long, J., … & Devercelli, G. (2020). Patient-reported burden of hereditary angioedema: findings from a patient survey in the United States. Annals of Allergy, Asthma & Immunology, 124(6), 600-607.
[3] Longhurst, H. J., & Bork, K. (2019). Hereditary angioedema: an update on causes, manifestations and treatment. British Journal of Hospital Medicine, 80(7), 391-398.
[4] HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]). Product Characteristics.
[5] CINRYZE® (C1 esterase inhibitor [human]). Product Characteristics.
[6] Farkas, H., Martinez–Saguer, I., Bork, K., Bowen, T., Craig, T., Frank, M., … & Zuraw, B. (2017). International consensus on the diagnosis and management of pediatric patients with hereditary angioedema with C1 inhibitor deficiency. Allergy, 72(2), 300-313.
[7] European Medicines Agency, TAKHZYRO Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/takhzyro-epar-product-information_en.pdf. Last Accessed: September 2023.
[8] Banerji, A., Busse, P., Christiansen, S. C., Li, H., Lumry, W., Davis-Lorton, M., Bernstein, J. A., Frank, M., Castaldo, A., Long, J. F., Zuraw, B. L., & Riedl, M. (2015). Current state of hereditary angioedema management: a patient survey. Allergy and asthma proceedings, 36(3), 213–217. https://doi.org/10.2500/aap.2015.36.3824
[9] Bork, K., Hardt, J., Schicketanz, K. H., & Ressel, N. (2003). Clinical studies of sudden upper airway obstruction in patients with hereditary angioedema due to C1 esterase inhibitor deficiency. Archives of Internal Medicine, 163(10), 1229-1235.
[10] Maurer M, Lumry WR, Li H, et al. Efficacy and Safety of Lanadelumab in Pediatric Patients Aged 2 to <12 years With Hereditary Angioedema: Results From the Open-Label, Multicenter Phase 3 SPRING Study. Abstract submitted to European Academy of Allergy and Clinical Immunology Hybrid Congress 2022.
[11] TAKHZYRO®(lanadelumab-flyo) injection. U.S. Prescribing Information.
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Fintech PR
President Emmerson Mnangagwa met this week with Zambia’s former Vice President and Special Envoy Enoch Kavindele to discuss SADC’s candidate for the AfDB
President Mnangagwa, who is SADC Chairperson, reaffirmed his own country’s and SADC’s enthusiastic support for Zambian candidate Sam Maimbo
LUSAKA, Zambia, Dec. 20, 2024 /PRNewswire/ — Special Envoy Kavindele released the following statement following the meeting:
“I am elated to witness the growing success and momentum of Sam Maimbo’s candidacy to become the next President of the African Development Bank. I am filled with gratitude to our friends across both SADC and COMESA for their continued support and good wishes.
Sam has garnered such wide consensus due to his being uniquely qualified to deliver the transformative change and empowerment our continent needs. Sam’s 30 years in development work is defined by driving outcomes, improving processes, and investing in people. The AfDB needs a hands-on leader who is laser focused on delivering results and who is unafraid of making tough decisions in order to best serve our continent. Sam is that leader. Sam has the track record and experience to drastically enhance the pace, scale, and impact of the Bank’s work in service of the people and governments of Africa.
Our region has a proud history of supporting fellow Southern Africans. For example, we all recall Lusaka’s role in hosting the African National Congress’ headquarters during the dark days of Apartheid oppression.
It therefore gives me no pleasure to observe my South African brothers, who have themselves leant on Zambia’s steadfast friendship over many decades, fail to rally behind both SADC and COMESA’s chosen candidate for the AfDB. Africa’s urgent economic development challenges demand transformational leadership at the AfDB, it is all of our responsibility to put forward the best candidate for the job. This is not the time or place for a government to act with narrow self-interest, we all must act in the continent’s and AfDB’s best interest.
I thank Sam Maimbo for his lifelong service to our entire continent, and I am eager to witness his enormous impact as President of the AfDB.”
LONDON, Dec. 20, 2024 /PRNewswire/ — Heimdal Security shares a practical holiday cybersecurity checklist, offering expert insights to help businesses safeguard against cyber threats this festive season.
With reduced staffing, remote work setups, and a surge in online shopping creating heightened vulnerabilities, this guide offers actionable tips to enhance business security.
Going beyond basic advice, the checklist also highlights the most common holiday scams and features videos showcasing real-life examples of Christmas-themed cyber scams and effective prevention strategies.
Key Tips to Protect Businesses This Holiday Season:
- Strengthen endpoints: Ensure devices are updated with antivirus and endpoint protection software; consider Endpoint Detection and Response (EDR) and application whitelisting.
- Prepare for phishing spikes: Train staff to identify suspicious emails, enforce robust email filters, and establish protocols for reporting unusual activity.
- Secure remote access: Mandate VPN usage, monitor unusual logins, and deactivate inactive accounts temporarily.
- Segment and shield networks: Isolate sensitive areas, deploy DNS security and advanced firewalls, and maintain full visibility over network traffic.
- Apply timely patches: Regularly update all systems and test patches in a controlled environment to minimize disruptions.
- Mitigate supply chain risks: Assess vendors thoroughly and limit their access to essential systems.
- Have a response plan ready: Tailor incident protocols for the holidays, create an on-call rotation for the IT team, and enable rapid action against suspicious activity.
“ Cybercriminals thrive on holiday distractions, but with proactive measures like phishing training, secure endpoints, and network segmentation, businesses can stay ahead of potential threats,” said Alex Panait, System Administrator at Heimdal Security.
Common Holiday Scams That Businesses Should Watch For:
Cybercriminals often tailor their tactics to exploit the festive season. The most common scams include:
- Spear phishing: Emails disguised as holiday bonuses or event invitations that steal credentials or spread malware.
- Malicious holiday E-Cards: Festive greetings that contain links deploying ransomware or spyware.
- Fake E-Commerce sites: Fraudulent websites offering discounts to steal payment information.
- Insider threats: Distracted or disgruntled employees mishandling or exploiting sensitive data.
- Corporate travel scams: Fake booking platforms targeting business travelers.
- Business email compromise (BEC): Fraudulent requests for urgent wire transfers during year-end financial rushes.
For more, read the full article here or watch the video on YouTube to see how these threats unfold and learn actionable prevention strategies.
About Heimdal:
Established in Copenhagen in 2014, Heimdal® empowers CISOs, security teams, and IT administrators to improve their security operations, reduce alert fatigue, and implement proactive measures through a unified command and control platform.
Heimdal’s award-winning cybersecurity solutions span the entire IT estate, addressing challenges from endpoint to network levels, including vulnerability management, privileged access, Zero Trust implementation, and ransomware prevention.
For further press information:
Madalina Popovici
Media Relations Manager
[email protected]
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Fintech PR
According to Tickmill survey, 3 in 10 Britons in economic difficulty: Purchasing power down 41% since 2004
The people who have the most problems are women (30%) and are between 35 and 49 years old (39%)
ROME, Dec. 20, 2024 /PRNewswire/ — The purchasing power in the UK has dropped by 41% over the last 20 years. Today, £100,000 left in a bank account since 2004 without being invested would now be worth £59,021.
This figure is one of the findings from a study conducted by Tickmill, an international online trading broker that compared the economic situation in the UK and the European Union through the infographic “Purchasing Power and Cost of Living: UK vs EU”.
The analysis reveals a slight decline of 0.4% in the UK’s purchasing power, which currently stands at £41,573. In contrast, the European Union has seen a modest rise of 0.1%, reaching £40,874.
Why is purchasing power declining in the UK? One key factor is the cost of living. If the UK were still part of the European Union, it would rank as the fifth most expensive country, behind Ireland, Luxembourg, Denmark, and the Netherlands.
Unsurprisingly, 3 in 10 Britons are struggling with the cost of living. Women (3 in 10, compared to 25% of men), those aged between 35 and 49 (4 in 10), households earning less than £15,000 (6 in 10), and single parents (1 in 2) are among the most affected groups.
Among UK nations, Northern Ireland is the hardest hit, with 34% of its population facing financial difficulties, followed by Wales (31%), England (28%), and Scotland (22%). In England, the North East has the highest percentage of people struggling, with 4 in 10 residents affected. Even in London, the high costs impact 1 in 4 adults.
In response to these challenges, Britons are making significant adjustments:
- 53% have cut back or delayed spending on smaller items like eating out, entertainment, subscriptions, clothing, toys, books, etc.;
- 52% have reduced household energy consumption;
- 48% have decreased their grocery spending;
- 41% have scaled back or postponed major expenditures, such as holidays, cars, and weddings;
- 26% are working longer hours, taking on overtime, or pursuing additional jobs to earn extra income.
The British also made changes on the financial side. One in four adults has been forced to dip into their savings or investments to cover daily expenses. Moreover, 44% have stopped saving or investing entirely or have reduced their savings and investments—a 4% increase compared to 2023.
The lack of investment is another critical factor contributing to the decline in purchasing power. It is estimated that 13 million UK residents hold £430 billion in cash deposits but do not invest. The reasons? Seventy-four percent say they cannot compare investment products effectively, and 43% are afraid of losing their money.
A lack of knowledge and fear are preventing many savers from taking advantage of an important opportunity: preserving or increasing their purchasing power in the long term.
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Fintech PR2 days agoAccording to Tickmill survey, 3 in 10 Britons in economic difficulty: Purchasing power down 41% since 2004