The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Takhzyro (lanadelumab) for the prevention of recurrent attacks of hereditary angioedema (HAE), in patients aged 12 years and older.
Takhzyro is the first monoclonal antibody for the prevention of HAE attacks. It has been designed to bind to kallikrein proteins, and thereby block the activity of the kallikrein-kinin system.
At its meeting last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that Takhzyro is of “major” benefit for public health and agreed to the applicant’s request for an accelerated assessment of this medicine.
The efficacy and safety of Takhzyro have been studied in a phase 3 clinical trial involving 125 patients. During 26 weeks of treatment, patients who received Takhzyro showed a significant reduction in total HAE attack rate and severity. The most common adverse events were injection site reactions of mild intensity.
The opinion adopted by the CHMP will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once the marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State.