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
DAY TWO OF HONG KONG INVESTOR SUMMIT TACKLES MEGATRENDS IMPACTING THE PLANET’S EIGHT BILLION CITIZENS
HONG KONG, Dec. 8, 2023 /PRNewswire/ — The Future Investment Initiative PRIORITY Summit Hong Kong today reconvened leaders from finance and government for a second day to address global matters of concern to humanity.
One thousand global investors, policy makers, innovators and business leaders were joined by counterparts from across Asia to discuss ‘megatrends’ including the unstoppable rise of Asia as an economic power, the impact of technology on lifestyles and jobs, and the deployment of capital between diverse markets and economies.
The day began with a presentation by FII Institute CEO Richard Attias and COO Rakan Tarabzoni of the Priority Compass Report, a global survey of 53,000 people across 23 countries. The survey revealed a sharp drop of 20% worldwide in people’s overall satisfaction with their lives, with respondents reporting concerns over cost of living, loneliness, technology, and climate concerns. 65% of people in countries polled are worried about day-to-day living costs. Loneliness has leaped up the list of concerns, with 41% of Asia’s population reporting frequent feelings of loneliness. 55% of people worldwide are worried about access to affordable and accessible healthcare and climate concerns continue to deepen as 78% of people across the Global South are worried about pollution.
Laurence Moroney, Lead AI Advocate at Google addressed concerns about AI and the risk of biases emerging because of reliance on narrow English language datasets. Moroney pointed out that 60% of information on Web 2.0 is generated by bots.
He also argued that innovators in AI need to account for distinctive local cultural identities in the development of AI models and explained that Google’s Gemini is working to condense and preserve cultures into small models, allowing people to interact with, learn about, and preserve individual distinctive cultures.
A panel discussion on cost of living heard Jerry Li, Founder and Managing Partner eWTP Arabia Capital describe data as the new oil, a resource driving innovation and progress. The 120 zettabytes (120, 000,000,000,000,000,000,000 bytes) generated in 2023 is expected to increase by over 150% in 2025, to 181 zettabytes.
During a panel discussion on the future of work Edith Yeung of Race Capital suggested that AI will free people from doing the things that they do not want to do, freeing them for more meaningful activities. The average person will spend 90,000 hours at work over a lifetime.
Raymond Yuan, CEO & Chairman CTH Group pointed out synergies between blockchain and AI starting to emerge in healthcare, life sciences, as well as financial services. The global Blockchain Market size was estimated to be approximately $7.4 billion in 2022 and the global artificial intelligence market $428 billion.
A panel of leading Asian venture capitalists debated ways in which Asia can grow vibrant and successful startup ecosystems, with $22.3 billion invested in Asian startups between July and September 2023.
Discussing the impact of investment on longevity and ageing Joshua Fink, Founder Luma Group, explained that revolutionary regenerative medicine, inspired by Nobel Prize-winning research, can reverse cells to a pre-disease state, offering hope against genetic diseases.
His Royal Highness Prince Faisal bin Bandar bin Sultan, Chairman, Saudi Esports Federation described the spectacular growth of gaming over the last 20 years at 12% per year. By the end of 2023 it is projected there will be 3.75 billion gamers in the world.
In a ‘titan of industry’ fireside chat with Sir Martin Sorrell, Richard Attias and Sorrell surveyed the global media sector, worth $950 billion, with digital projected to comprise 70% by 2025. On the future of platforms such as TikTok Sorrell explained that with young people’s views being shaped by new forms of social media, issues surrounding data safety and privacy will continue. Discussing ‘hyper personalization’ he pointed out that Coca Cola is thinking about the potential for AI to target individual messages to consumers.
Rakan Tarabzoni, COO, FII Institute presented the summit with FII’s inclusive ESG tool, launched to help companies in emerging markets improve sustainability and help investment capital find current and future performance leaders. The tool, which has been made publicly available will address biases inbuilt in other ESG methods and may unlock a $5.4 trillion funding gap of investments into emerging markets.
In the final session HE Kjell Magne Bondevik former Prime Minister of Norway and President, Oslo Centre for Peace and Human Right declared himself convinced that businesses that take more seriously the concerns of common people will be the businesses that will thrive in the future.
The FII Institute has worked with HKEX and consulting firm Deloitte to offset the carbon emissions generated by the summit, by purchasing credits on the HKEX Core Climate exchange, exemplifying a shared conviction that purposeful markets and business can serve humanity as a force for good.
During the summit BOC International signed a strategic cooperation framework agreement with SPIC International Finance (Hong Kong) Company Ltd. on green finance, bond investment and issuance, and global capital management. The signing was witnessed by Mr. Paul Chan, Financial Secretary of Hong Kong SAR.
The summit, held in partnership with Hong Kong Exchanges and Clearing Limited (HKEX), took place at HKEX Connect Hall.
The FII PRIORITY Summit Hong Kong continues conversations held in Riyadh last month. It is part of an ongoing global programme of summits, to be held next year in Miami (February) Brazil (June) and Africa (September))
Richard Attias, CEO of the Future Investment Initiative Institute said:
“I should like to thank Hong Kong Government, the Hong Kong Exchange and the people of this fabulous city for the welcome they have shown us this week. As the world charts its forward course we must be mindful at every turn of the issues that matter. Whether it’s cost of living, developing new modes of payment, new social media platforms, or poverty, it is investment and innovation that can make the difference. The investors and innovators here this week have taken these issues seriously and the conversations and hard work will continue as we strive for a better tomorrow.”
For media inquiries, please contact:
Email: [email protected]
About FII Institute
The Future Investment Initiative (FII) Institute is a global non-profit foundation driven by data with an investment arm and one agenda: Impact on Humanity. Global and inclusive, we foster great minds from around the world and turn ideas into real-world solutions in four critical areas: Artificial Intelligence (AI) & Robotics, Education, Healthcare and Sustainability.
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VICTORIA, Seychelles, Dec. 8, 2023 /PRNewswire/ — OrangeX, a global cryptocurrency exchange, is proud to unveil its $5 million Innovation Fund. Designed to bolster the Bitcoin ecosystem and propel blockchain innovation, the Fund’s core focus is on investing in promising projects within the Bitcoin ecosystem, including Ordinals Protocols and BRC-20 standard tokens.
In the dynamic landscape of the evolving Bitcoin ecosystem, various features and functionalities are continually reshaping its potential. Notably, the BRC-20 token standard has emerged as a key player, attracting significant attention.
Recognizing the surging demand and immense potential of BRC-20 standard token projects, OrangeX’s Innovation Fund stands ready to provide crucial capital and infrastructure support to empower the community in building a resilient and flourishing Bitcoin ecosystem.
Exciting Bitcoin Ecosystem Initiatives
OrangeX is proud to introduce a range of products and services tailored for the Bitcoin ecosystem and projects, catering to user preferences. Key offerings include:
- Bitcoin-based Token Trading: Facilitating the listing and trading of Bitcoin-based tokens. ORDI, the largest BRC-20 token, is now available on both OrangeX Spot and Perpetual Contracts.
- Bitcoin Ecosystem Information: Providing valuable insights and analytics on the Bitcoin ecosystem.
- Bitcoin Ecosystem Token Launchpad: Offering a fair and efficient token distribution service for promising Bitcoin ecosystem projects with financial, technical, and marketing assistance. Share early ecosystem returns with a larger customer base. Interested project owners can contact [email protected] for more information.
OrangeX CEO, Alexandra K, expressed confidence in the potential of outstanding Bitcoin Ecosystem projects. He stated, “These projects not only stand to receive financial backing from OrangeX but also gain access to a suite of services, resources, and connections available through our platform. With these tools, we believe our supported projects will thrive, succeed, and have a positive impact on the world.”
Empowering the Bitcoin Ecosystem: OrangeX’s Pioneering Role
Bitcoin, the original cryptocurrency, remains the bedrock of blockchain finance. Every trading platform benefits from the development of Bitcoin. If there is no Bitcoin, cryptocurrency exchange will no longer exist. With 15 years since its inception, the Bitcoin revolution continues to unfold, presenting a dynamic and evolving ecosystem. Anticipate groundbreaking innovations that will redefine possibilities.
As a central figure in this domain, every cryptocurrency exchange is urged to actively contribute to the ongoing development of the Bitcoin ecosystem. OrangeX, as a trailblazer, introduces the Innovation Fund, a platform committed to integrating Bitcoin ecosystem products. This initiative aims to address user needs in exchanging, managing, and investing in Bitcoin-based projects.
OrangeX invites collaboration from institutions, communities, and projects to join forces in propelling the growth and diversification of the Bitcoin ecosystem. Together, let’s forge a future where Bitcoin is more accessible, versatile, and inclusive – ensuring its enduring significance in the ever-evolving landscape of blockchain-based finance.
About OrangeX
Founded in 2021 in Seychelles, OrangeX stands as a worldwide cryptocurrency trading platform renowned for its cutting-edge technology, proficient team, and seasoned financial knowledge. With more than 1 million active users, OrangeX has built a comprehensive product line, dedicated to empowering investors to make a better future. OrangeX futures trading offers 3 service options: USDT-M Perpetual Contracts, One-Click Copy Trading and Powerful API. According to Coinmarketcap(CMC) and CoinGecko, OrangeX Spot now supports over 100 coins with approximately 130 trading pairs.
For more information, please visit: Website | Twitter | Telegram | CoinMarketCap | CoinGecko
For media inquiries, please contact: [email protected]
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SHENZHEN, China, Dec. 8, 2023 /PRNewswire/ — On December 8, the 2023 Shenzhen Global Investment Promotion Conference was held in Shenzhen, China. Over 380 projects were signed, with a total investment of 1 trillion yuan. The event was attended by more than 1,000 distinguished guests from countries and regions including the United States, Japan, and the EU.
Shenzhen, an open city, is extending invitations to global investors. Under the theme of “Create New Paradigms, Embrace Shared Opportunities — Invest in Shenzhen, Build a Winning Future”, the Conference took place in the format of “1+1+12+N” events, according to the Commerce Bureau of Shenzhen Municipality. Specifically, it consists of one main event, namely the Investment Promotion Conference and the Shenzhen City Summary Meeting on Investment Promotion; one Investment Outcome Exhibition Area; 12 district-level investment promotion conferences; and several overseas parallel sessions and industrial investment promotion activities. Ten overseas parallel sessions were staged in Madrid, Zurich, Hawaii, Vancouver, San Diego, Brisbane, Chicago, Tokyo, Sydney, and Milan. 12 industry investment promotion activities were held on various topics, including energy storage, digital energy, finance, consumption, talent attraction, and high-tech industries.
A favorable business environment serves as the best “Chinese parasol tree”, the greatest “magnet”, and the core competitiveness of a city. The Conference showcased investment opportunities and policies for investing in Shenzhen as well as presented Shenzhen’s first-class business environment to the world. Shenzhen has ranked among the top in China’s business environment evaluations for all 18 indicators. With a flourishing private economy, Shenzhen boasts a total of 4.16 million registered business entities and ranks first nationwide for the total quantity and density of entrepreneurship.
The excellent business environment has made Shenzhen a popular land for international investment, and multinational companies maintain promising prospects for investment in the city. Thomas Triomphe, Global Executive President of Sanofi Pasteur, expressed confidence in the tremendous potential Shenzhen holds for the future. “This is an incredible city. The technological and economic development in Shenzhen has been impressive over the past few years,” said David Kohler, Chairman and CEO of Kohler Group.
This year, the Conference set up the Investment Outcome Exhibition Area for the first time to present the investment outcomes and development plans of the districts and departments of the city in recent years. An area was also set up for an exhibition on local renowned brands to display products in advanced manufacturing, consumer electronics, trendy lifestyles, and the new-style tea industry.
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