Takeda’s TAKHZYRO® (lanadelumab-flyo) Prefilled Syringe Now Available for People With Hereditary Angioedema (HAE) Ages 12 Years and Older in the United States

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced TAKHZYRO^® (lanadelumab-flyo) injection single-dose prefilled syringe is now available in the U.S. to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.¹ HAE is a rare genetic disease that results in recurrent attacks of edema (swelling) in various parts of the body, which can be burdensome, debilitating and potentially life-threatening.^2,3,4 Approved by the U.S. Food and Drug Administration on February 8, 2022, the TAKHZYRO prefilled syringe is ready to use and requires fewer preparation steps than the single-dose vial, enhancing the treatment administration experience.¹

“By introducing TAKHZYRO prefilled syringe to the HAE community, our aim is to continue to enhance the patient experience. With this advancement, those taking TAKHZYRO can now live their life with a ready-to-use option that requires fewer steps and less waste than when using the single-dose vial to receive their injection,” said Cheryl Schwartz, senior vice president, Rare Disease Business Unit at Takeda Pharmaceutical Company Limited. “Over the coming months, we will be working with patients and their specialty pharmacies as they are ready to make the transition.”

With a proven efficacy and safety profile and real-world experience, TAKHZYRO has been available in the U.S. since 2018 helping to prevent HAE attacks in patients 12 and older. TAKHZYRO is supported by a robust clinical development program, which includes one of the largest prevention studies in HAE with the longest active treatment duration, HELP (Hereditary Angioedema Long-term Prophylaxis) Study™.¹ Results from the HELP Study Open-Label Extension (OLE) found consistent safety and efficacy results with TAKHZYRO in a treatment period of up to 132 weeks.^1,5

“HAE attacks are unpredictable, debilitating and in some cases life-threatening, adding uncertainty and complexity to the daily lives of those living with this disease and their families,” said Dr. William Lumry, Allergy Immunology Specialist, Clinical Professor of Internal Medicine, University of Texas Southwestern Medical School. “After many years in practice witnessing the ups and downs of this disease, I welcome any opportunity to simplify the process of administering an effective prevention therapy for people living with HAE."

TAKHZYRO Important Safety Information

TAKHZYRO may cause serious side effects, including allergic reactions. Call your healthcare provider or get emergency help right away if you have any of the following symptoms:

• wheezing
• difficulty breathing
• chest tightness
• fast heartbeat
• faintness
• rash
• hives

The most common side effects seen with TAKHZYRO were injection site reactions (pain, redness, and bruising), upper respiratory infection, and headache.

These are not all the possible side effects of TAKHZYRO. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088.

TAKHZYRO has not been studied in pregnant or breastfeeding women. Talk to your healthcare provider about the risk of taking TAKHZYRO if you are pregnant, plan to be pregnant, are breastfeeding, or plan to breastfeed.

Please see full Prescribing Information, including information for patients.

About Hereditary Angioedema

HAE is a rare genetic disease that results in recurring attacks of edema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.^2,3,4 Attacks that obstruct the airways can cause asphyxiation and are potentially life-threatening.^4,7 HAE affects an estimated 1 in 50,000 people worldwide.⁶ It is often under-recognized, under-diagnosed and under-treated.⁴

Takeda in Hereditary Angioedema

Hereditary Angioedema (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 TAKHZYRO^® (lanadelumab-flyo) Injection

TAKHZYRO is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 12 years of age. TAKHZYRO is intended for self-administration or administration by a caregiver with subcutaneous injection of 300 mg/2 mL (150 mg/1 mL) solution in a single-dose prefilled syringe, which was approved by the U.S. Food and Drug Administration (FDA) in February 2022, or in a single-dose vial every 2 weeks. A dosing interval of every 4 weeks may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months. The patient or caregiver should be trained by a healthcare professional.¹ TAKHZYRO is currently approved and available in more than 30 countries around the world.

About Takeda

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. For more information, visit https://www.takeda.com.

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 briefing 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. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

1. TAKHZYRO^® (lanadelumab-flyo) injection Prescribing Information.
2. 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.
3. Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
4. Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.
5. Banerji A, Bernstein JA, Johnston DT, et al. Long-term prevention of hereditary angioedema attacks with lanadelumab: the HELP OLE Study. Allergy. Published online July 21, 2021. doi:10.1111/all.15011
6. Busse P, Christiansen S, Riedl M et al. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema. J Allergy Clin Immunol Pract. 2021;9:132-50.
7. Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.