Takhzyro (lanadelumab-flyo) is indicated for the preventive treatment of hereditary angioedema (HAE) in patients aged 12 years and older.
One of the first novel monoclonal antibodies (mAb) for HAE treatment, the drug was initially developed by US-based pharmaceutical company Dyax, which was acquired by Ireland-based biotechnology company Shire in January 2016 for approximately $5.9bn. Takhzyro™ was also added to Shire’s portfolio as a result of the acquisition.
The US Food and Drug Administration (FDA) accepted a biologics license application (BLA) for Takhzyro™ in February 2018 under priority review status. The drug was approved by the FDA in August 2018. Takhzyro™ was approved by Health Canada in September 2018.
Shire has also submitted a marketing authorisation application (MAA) for Takhzyro™ to the European Medicines Agency (EMA), which has granted accelerated assessment of the drug.