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) from Takeda Pharmaceutical Company Limited.
Takhzyro is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of HAE in patients aged 12 years and older.
“Our goal is to continuously innovate in all areas of HAE management,” says 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. 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.