Shire gains EU approval for rare disease therapy Takhzyro

Ireland-incorporated rare disease specialist Shire (LSE: SHP) has been granted European approval for Takhzyro (lanadelumab) for routine prevention of attacks of hereditary angioedema (HAE), a rare, genetic and potentially life-threatening disorder.

The approval grants authority to market Takhzyro to prevent recurrent attacks of HAE in patients aged 12 years and older.

The decision from the European Medicines Agency follows approval in the USA on August 23, 2018 and in Canada on September 19, 2018, and was based on data from the Phase III HELP study, which were published in JAMA.