Takeda Receives Positive CHMP Opinion for Pre-filled Syringe of TAKHZYRO® (lanadelumab) to Prevent Hereditary Angioedema Attacks in Patients Aged 12+

June 09, 2020 /Bio ValleyBIOON/ -- Takeda recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of the pre-filled syringe formulation of Takhzyro (lanadelumab). Takhzyro is a subcutaneous prescription medication approved for routine prophylaxis in patients aged 12 years and older.Heredityrecurrence of hereditary angioedema (HAE). The European Commission (EC) is expected to make an approval decision within the next two months. Takeda anticipates launching the pre-filled syringe formulation of Takhzyro in Europe later this year. The market introduction of this product will enhance the treatment management experience for HAE patients receiving Takhzyro therapy.

HAE is a rareHeredityHereditary angioedema (HAE) is a genetic disorder that causes recurrent episodes of swelling in various parts of the body, including the abdomen, face, feet, genitals, hands, and throat. In the European Union and the United States, Takhzyro is the first monoclonal antibody approved for the treatment of HAE.

Takhzyro was approved by the European Union in November 2018, based on the Phase III HELP (Genetics(Long-term Prophylaxis of Hereditary Angioedema) Study Results. This was a large-scale prophylactic study that enrolled 125 patients aged 12 years and older with type I/II hereditary angioedema (HAE) to evaluate the efficacy and safety of subcutaneous Takhzyro versus placebo over 26 weeks. The results showed that the study met all primary and secondary endpoints: compared with the placebo group, patients receiving three Takhzyro dosing regimens experienced a significant reduction in the mean number of monthly HAE attacks. Specifically, the group treated with Takhzyro 300 mg every two weeks (n=27) demonstrated an 87% significant reduction in monthly HAE attack rates compared with the placebo group.

Currently, Takhzyro is supplied as a 300 mg injection in vials. The pre-filled syringe is the next-generation, fully assembled product that requires fewer preparation steps than the current vial format, while also reducing supply complexity and waste.

Isabel Kalofonos, Global Product Strategy Lead for HAE at Takeda, stated: “Our goal is to continuously innovate across all areas of HAE management. This positive opinion from the CHMP marks another significant step forward as we strive to enhance the treatment experience for patients receiving Takhzyro. We look forward to introducing this innovative pre-filled syringe to the European HAE community later this year and continuing our plans to expand to other regions worldwide in the coming months.”

Hereditary Angioedema (HAE) is a rareGeneticsHereditary angioedema (HAE) is a disease that can cause recurrent episodes 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. Episodes involving airway obstruction may lead to asphyxiation and can be life-threatening. HAE affects approximately 1 in 50,000 people worldwide, and the condition is often underdiagnosed.DiagnosisUnder-treatment and inadequate treatment.

Takhzyro is a fully human monoclonal antibody that specifically binds to and inhibits the activity of plasma kallikrein. The drug is produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology.

Takhzyro is administered via subcutaneous injection and has a half-life of 14 days in patients with hereditary angioedema (HAE). After training by healthcare professionals, the injection can be self-administered by the patient or administered by a caregiver, and can be completed in one minute or less. Regarding dosing, the recommended starting dose of Takhzyro is 300 mg every two weeks. In patients whose condition is well-controlled with no attacks during treatment, a dose of 300 mg every four weeks may be considered, particularly in patients with low body weight. (Bioon.com)

Original Source: Takeda Receives Positive CHMP Opinion for Pre-filled Syringe Presentation of TAKHZYRO® (lanadelumab) for use as a Preventive Treatment for Hereditary Angioedema Attacks