Takeda Receives Positive CHMP Opinion For Pre-Filled Syringe Presentation Of TAKHZYRO Lanadelumab For Use As A Preventive Treatment For Hereditary Ang
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of TAKHZYRO® (lanadelumab). TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. HAE is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.1,2,3
“Our goal is to continuously innovate in all areas of HAE management,” said Isabel Kalofonos, Global Product Strategy Lead, HAE, Takeda. “This positive opinion marks another important step forward as we aim to enhance the experience of treatment administration for people receiving TAKHZYRO. We look forward to bringing the pre-filled syringe innovation to the HAE community in Europe, starting later this year, and continue to progress plans to expand to other geographies in future months.”
TAKHZYRO received European approval in November 2018 based on results of the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™, which measured the reduction in the number of mean monthly HAE attacks in patients receiving treatment with TAKHZYRO versus placebo.4 It is currently available as a 300 mg solution for injection, presented in a vial. The pre-filled syringe is a next generation fully assembled presentation that requires fewer preparation steps than the current TAKHZYRO vial injection, while also reducing supplies and waste.
The EMA’s Type II Variation to the terms of the marketing authorisation is for medicines that have some type of change, such as administration method, but it does not involve a change to the medicine’s active substance. The CHMP opinion states that the European Commission (EC) decision will be adopted within 12 months, and under the terms of this Type II Variation, Takeda can proceed to commence launches of the TAKHZYRO pre-filled syringe in Europe later this year.
Further regulatory submissions for the pre-filled syringe presentation are under review or planned in other countries during 2020 and beyond.
About Hereditary Angioedema
Hereditary angioedema (HAE) is a rare genetic disorder that results in recurrent 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.1,2,3 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.2,3 HAE affects an estimated 1 in 50,000 people worldwide. It is often under-recognized, under-diagnosed and under-treated.1,5
About TAKHZYRO® (lanadelumab)
TAKHZYRO (lanadelumab) is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity. TAKHZYRO is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.6
TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks in patients with HAE. TAKHZYRO is intended for the self-administration or administration by a caregiver, only after training by a healthcare professional.6
TAKHZYRO Safety Information for Europe
Please consult the TAKHZYRO Summary Product Characteristics (SmPC) before prescribing. https://www.ema.europa.eu/en/documents/product-information/takhzyro-epar-product-information_en.pdf.
TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.6
Hypersensitivity to the active substance or to any of the excipients.
Warnings and Precautions
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.