De Monitor schreef op 4 december 2018 10:44:
Shire plc SHPG announced that the European Commission (EC) has granted marketing approval to Takhzyro (lanadelumab) subcutaneous injection, for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Takhzyro is the first monoclonal antibody to get approval for the preventive treatment of HAE in patients aged 12 years and older in the European Union. The recommended starting dose is 300 mg lanadelumab every two weeks.
HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body.
Notably, Takhzyro received approval for the same indication in the United States in August 2018 and in Canada in September 2018.
The European approval was supported by data from a phase III HELP study, which showed that patients taking Takhzyro 300 mg every two weeks had an 87% reduction in mean monthly HAE attacks versus placebo, while the patients taking Takhzyro 300 mg every four weeks had 73% reduction in attacks.
A pre-specified, exploratory analysis showed that 44% of the patients (n=27) receiving Takhzyro 300 mg every two weeks had zero attacks compared to placebo for the 26-week treatment period. Further, a post hoc analysis of the 16-week period from day 70 to day 182 showed that 77% of patients (n=26) treated with Takhzyro in the same dosage arm of the study were attack-free compared to placebo.
Shares of Shire have increased 14.1% year to date against the industry 's decline of 7.3%.
m.nasdaq.com/article/shires-takhzyro-...