Takeda announces FDA approval of the TAKHZYRO injection single-dose prefilled syringe for treatment of hereditary angioedema; approval offers new option in addition to vial injection

Sample article from our Government & Public Policy

CAMBRIDGE, Massachusetts , February 9, 2022 (press release) –

Takeda (TSE:4502/NYSE:TAK) today announced the U.S. Food and Drug Administration (FDA) approval of the TAKHZYRO® (lanadelumab-flyo) injection single-dose prefilled syringe (PFS) to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. The PFS is ready to use and requires fewer preparation steps than the current TAKHZYRO vial injection, while also reducing supplies and waste.1

“Today’s announcement is an important innovation for TAKHZYRO, offering people living with HAE and their caregivers an enhanced treatment administration experience with proven sustained reduction of attacks,” said Cheryl Schwartz, Senior Vice President, Rare Disease Business Unit at Takeda Pharmaceutical Company Limited. “This product delivery enhancement is intended to improve the overall patient experience and reflects Takeda’s continued commitment to the HAE community; we look forward to introducing this new option to patients later this year.”

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.1,2 TAKHZYRO is currently approved and available in more than 30 countries around the world.

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.3,4,5 Attacks that obstruct the airways can cause asphyxiation and are potentially life-threatening.4,5  HAE affects an estimated 1 in 50,000 people worldwide. It is often under-recognized, under-diagnosed and under-treated.3,6

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 or in a single-dose vial every 2 weeks. Dosing every 4 weeks may be considered in some patients. The patient or caregiver should be trained by a healthcare professional.1 

TAKHZYRO Safety Information for United States
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 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.

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Jason Irving
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