LONDON (Alliance News) - Shire PLC said Tuesday it has published the full results of its phase III Help study of its hereditary angioedema drug Lanadelumab showing that the study met all of its primary and secondary endpoints.
Lanadelumab is approved under the brand name Takhzyro in the US and Canada for the treatment of hereditary angioedema, a condition which causes swelling in different parts of the body and can be life-threatening.
The mean number of monthly disease attacks reduced by 87% in patients given 300 milligrams of Lanadelumab every two weeks when compared to placebo.
Moreover, at the same dose, patients had 83% fewer moderate to severe attacks when compared to placebo and 87% fewer requiring on-demand treatment. Patients also experienced an 89% attack rate reduction from days 14 to 182 of the study.
Over the 26 week period of study, 44% of patients taking Lanadelumab at the 300 milligram dose were attack-free, compared to only 2% of patients taking the placebo.
Lanadelumab is taken as an injection with the most commonly reported side effect being pain around the injection site, with 43% of patients reporting this.
Viral upper respiratory tract infection was reported in 24% of patients taking Lanadelumab and headache in 20%. Erythema or redness around the injection site was seen in 10% of patients, and bruising in 7%, while dizziness was reported in 6%.
99% of adverse events were mild or moderate in their severity and there were no deaths of related serious adverse events during the study period.
The Help study evaluated both the efficacy and safety of Lanadelumab compared to placebo in 125 patients aged 12 years or older with hereditary angioedema.
Lanadelumab has been approved in the US and Canada and further regulatory submissions for the drug are ongoing.
"Data from Help demonstrate the efficacy of Lanadelumab in preventing [hereditary angioedema] attacks over the entire duration of the study, with many patients remaining attack-free during the 16-week steady state period. We remain focused on our work to help make Lanadelumab available to patients living with [hereditary angioedema] in additional countries around the world," said Shire's head of global affairs and immunology, Donatello Crocetta.
