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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

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  •  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 

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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.

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[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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Statement From Universal Music Group N.V.

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HILVERSUM, Netherlands, Nov. 9, 2024 /PRNewswire/ — “We have taken note of Bill Ackman’s post in relation to Pershing Square and UMG on X yesterday. Neither UMG nor any of its other board members were involved in the formulation of the views in that post. As disclosed in UMG’s listing prospectus, Pershing has the right to request a listing in the US subject to a Pershing entity selling at least $500 million in UMG shares as part of the listing. Pershing does not have any right to require UMG to become a US domiciled company or delist from Euronext Amsterdam. While the company will endeavor in good faith to comply with its contractual obligations with respect to undertaking the process of a US listing at the request of Pershing, any actions or decisions beyond those necessary to comply (including any decisions to change the domicile of the company) will be based on an analysis taking into account what is value maximizing and in the best interests of all the shareholders of the company.”

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Manulife Investment Management aligns capabilities across regions under the newly created role of Global Emerging Market Equities CIO

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LONDON, Nov. 8, 2024 /PRNewswire/ — Manulife Investment Management today announced enhancement to its equity organization in leveraging expertise across its Asia and Emerging Markets teams to improve investment experience for its clients.  Charlie Dutton, an equity investment leader with substantial experience in Asia, is named to the newly created role of Chief Investment Officer, Global Emerging Market Equities. In this new role, Charlie will oversee and align our Asia ex-Japan and emerging market equity capabilities, ensuring we leverage local resources and insights across the organization.

Manulife Investment Management has operated in emerging markets for more than a century. Today, it has one of the largest equity teams based in Asia with over 90 investment professionals located across 10 markets in the region. By combining local insight with deep investment expertise, Manulife Investment Management will be able to leverage deeper information advantage over other asset managers based outside of Asia. The combined Emerging Market Equities organization manages over US$25 billion in AUM across Asia and emerging markets equity strategies.

“Collaboration and engagement have always been at the heart of our investment culture, and our emerging markets and Asia equity teams have participated in a variety of forums to exchange ideas and insights.  The closer alignment of the Asia equity team with the global Emerging Markets equity organization formalizes the longstanding sharing of ideas and insights between our Asia and our emerging markets equity teams.  We believe this alignment will translate into improved research sharing and investment decision making, and will enhance our ability to create custom-tailored solutions to meet client needs,” said Colin Purdie, Global Chief Investment Officer, Public Markets, Manulife Investment Management.

Charlie will be spending a considerable amount of time in Asia with the extensive investment teams across the region in the coming months. He will continue to be based in London, affording him the opportunity to work and communicate with the investment teams in London and across Asia effectively, ensuring connections between each.

Charlie brings more than 27 years of investment experience to this role, including over 25 years of Asia equity investment experience with seven years in Hong Kong as well as South Africa and London. Prior to joining Manulife Investment Management’s Emerging Markets Equity team earlier this year, Charlie was a fund manager at Ninety One as part of the Global Quality Capability team that managed assets across five strategies.

Before Ninety One, Charlie was a founding partner at Coupland Cardiff, an Asian investment firm, where he spent 10 years managing Asian focused equity funds. Prior to that, he was based in Hong Kong and served as director of Asia-Pacific research at JPMorgan and as a Hong Kong/China consumer analyst at JF Securities. Charlie started his career at HSBC based in Hong Kong as a HK/China Analyst.

“We are confident Charlie’s deep investment experience, including over 25 years investing in Asia equity, makes him ideally suited to take on the role of CIO, Emerging Markets Equities. We look forward to his leadership, combined with the support of our Asia investment teams, in building upon our strong foundation in the region, and leading our Asia business into the future,” said Steve Medina, Chief Investment Officer, Global Equities, Manulife Investment Management.

At the same time, Manulife Investment Management announced that Kathryn Langridge, Senior Managing Director, Senior Portfolio Manager, and Head of Emerging Markets Equity team, has shared her intention to retire effective October 31, 2025, after an impressive investment career spanning over 40 years.  Meanwhile, Ronald Chan, CIO, Asia ex-Japan Equity, is departing Manulife Investment Management.

“The alignment of the Asia and the Emerging Markets equity teams is a testament to the critical role Asia plays in today’s equity markets, and further draws attention to the deep pool of talent in Manulife’s investment organization,” said Charlie Dutton, Chief Investment Officer, Global Emerging Market Equities. “By globalizing and strengthening this capability, Manulife Investment Management is better positioned to deliver for its clients while expanding the pipeline of research and insight the Emerging Markets equity team can deliver for other capabilities at the firm on a global basis.”

About Manulife Wealth & Asset Management

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As part of Manulife Financial Corporation, Manulife Wealth & Asset Management provides global investment, financial advice, and retirement plan services to 19 million individuals, institutions, and retirement plan members worldwide. Our mission is to make decisions easier and lives better by empowering people today to invest for a better tomorrow. As a committed partner to our clients and as a responsible steward of investor capital, we offer a heritage of risk management, deep expertise across public and private markets, and comprehensive retirement plan services. We seek to provide better investment and impact outcomes and to help people confidently save and invest for a more secure financial future. Not all offerings are available in all jurisdictions. For additional information, please visit manulifeim.com

Media contacts: Carl Wong, Manulife Investment Management Asia, +852 2510 3180, [email protected]; Elizabeth Bartlett, Head of Wealth & Asset Management Public Relations, North America & Europe, Manulife Investment Management, +1 857 210 2286, [email protected]

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Palm Jebel Ali Project Surges Ahead in 2024: Milestones Achieved in Record Time for Dubai’s Most Anticipated Development

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DUBAI, UAE, Nov. 8, 2024 /PRNewswire/ — Nakheel, a member of Dubai Holding’s pioneering real estate arm Dubai Holding Real Estate, has marked significant progress in the development of Palm Jebel Ali in 2024, with the project progressing at pace to meet 2025 milestones.

The development masterplan was approved by His Highness Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai in May 2023, who said at the time; “Palm Jebel Ali will further strengthen our urban infrastructure and consolidate the city’s emergence as one of the world’s leading metropolises. This new groundbreaking project reflects our strategic development plan centred on raising the quality of life and happiness of residents.”

The Palm Jebel Ali area received further recognition this year when His Highness Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister, Minister of Defence, and Chairman of The Executive Council of Dubai, approved the master plan for the 6.6 kilometre development of Jebel Ali Beach. The project includes a five-kilometre sandy beach, to be developed by Nakheel, as well as a 1.6-kilometre-long Mangrove Beach, to be developed by Dubai Municipality.

Khalid Al Malik, Chief Executive Officer of Dubai Holding Real Estate, said; “At Nakheel we believe in developing dreams, inspired by the vision of our leaders and the hopes of our people. The rapid progress we are currently witnessing on ground at Palm Jebel Ali is testimony to the grand success of our key partnerships and our joint endeavours to ensure we deliver on our commitments.”

Several key contracts for the project were awarded throughout 2024, including the construction of a new 6-kilometre road, the contracts for the island’s marine works, dredging, land reclamation, beach profiling and sand placement, directly supporting the construction of villas. The first eight fronds of the project are expected to be site-ready for villa infrastructure and civil works by the first quarter of 2025.

Crucially, the contract for the construction of exclusive ultra-luxury villas on the first six fronds of the project has also been awarded and are scheduled for completion by late 2026. Nakheel recently announced their partnership with Dubai Electricity and Water Authority for the development of two substations on Palm Jebel Ali.

Video: Palm Jebel Ali

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Palm Jebel Ali three major contracts signing ceremony

 

Groundbreaking ceremony of marine works on Palm Jebel Ali with Jan De Nul Dredging LTD

 

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