Takeda Receives U.S. FDA Approval for TAKHZYRO (lanadelumab) Prefilled Syringe for Preventive Treatment of Hereditary Angioedema in Patients Aged 12 and Older

News on February 23, 2022 /BioValleyBIOON/ -- Takeda Pharmaceutical Company Limited recently announced that the U.S. Food and Drug Administration (FDA) has approved Takhzyro (lanadelumab, lanadelumab injection) single-dose pre-filled syringe (PFS),For Ages 12 and AboveGeneticsPatients with Hereditary Angioedema (HAE), routine prevention of HAE attacks.This PFS is a ready-to-use product that requires fewer preparation steps compared to the current Takhzyro vial injections, while also reducing supply and waste.

Takhzyro is supported by a robust clinical development program, which includes one of the largest and longest preventive studies in HAE. Currently, Takhzyro has been approved and marketed in more than 30 countries worldwide.

Cheryl Schwartz, Senior Vice President of Takeda’s Rare Disease Business Unit, stated: “Today’s approval represents a significant innovation for Takhzyro, offering enhanced treatment experiences and sustained reduction in attacks for HAE patients and their caregivers. This product aims to improve the overall patient experience, reflecting Takeda’s ongoing commitment to the HAE community; we look forward to bringing this new option to HAE patients later this year.”

Long-term prophylactic treatmentHeredityFinal Results of Two Analyses from the Global Phase 3 HELP Study Open-Label Extension (OLE) in Patients with Hereditary Angioedema (HAE) Aged ≥12 Years. The OLE evaluated the long-term safety (primary endpoint) and efficacy of Takhzyro 300mg administered every two weeks for up to 2.5 years.

Hereditary Angioedema (HAE) is a rareGeneticsSexual diseases can lead to recurrent edema-swelling in various parts of the body (including the abdomen, face, feet, genitals, hands, and throat). The swelling can be debilitating and painful. Episodes that obstruct the airway can cause suffocation and may be life-threatening. It is estimated that 1 in every 50,000 people worldwide suffers from HAE, a condition that is often underestimated.DiagnosisInsufficiency and undertreatment.

Takhzyro is the first monoclonal antibody approved for the treatment of HAE., was approved for marketing in August 2018. Indications: For routine prevention of HAE attacks in patients aged 12 years and above with HAE. Takhzyro is not indicated for the treatment of acute HAE attacks. Takhzyro is a fully human monoclonal antibody that specifically binds to and inhibits the activity of plasma kallikrein. The drug is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.

Takhzyro is administered via subcutaneous injection, with a half-life of 14 days in HAE patients. After training by healthcare professionals, it can be self-administered by the patient or administered by a caregiver, with the injection completed in 1 minute or less. The recommended starting dose of Takhzyro is 300mg every 2 weeks. For patients who have achieved good control of their condition without attacks, a dose of 300mg every 4 weeks may be considered, especially in patients with lower body weight. Depending on regional approval, Takhzyro is available as a 300mg vial or pre-filled syringe. (Bioon.com)

Source of Original Text:Takeda Receives U.S. FDA Approval for Prefilled Syringe Presentation of TAKHZYRO (lanadelumab-flyo) for Use as a Preventive Treatment for Hereditary Angioedema Attacks