Shire's lanadelumab gets one step closer to European approval

19th Oct 2018 14:38

(Sharecast News) - Rare disease-focussed biotechnology company Shire announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorisation of 'lanadelumab' injection, for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.The FTSE 100 company said that if approved, lanadelumab would be a first-of-its-kind, fully human monoclonal antibody (mAb) available in the European Union that inhibited the activity of plasma kallikrein - an enzyme which was uncontrolled in people with HAE - to help prevent attacks.Shire described HAE as a rare, genetic disorder estimated to affect about one in 10,000 to one in 50,000 people worldwide.It said the condition resulted in recurring attacks of oedema, or swelling, in various parts of the body, including the abdomen, face, feet, genitals, hands and throat, that could be debilitating and painful.Laryngeal attacks that obstructed the airways were potentially life-threatening due to the risk of asphyxiation."This positive opinion marks an important step towards providing adults and adolescents living with HAE in Europe a first-of-its-kind monoclonal antibody treatment option to help prevent attacks," said Shire's executive vice-president and head of research and development Andreas Busch."We are excited about the future potential of lanadelumab in helping to address the needs of those living with this chronic and unpredictable disease."The company said the positive opinion was supported by data from the phase III hereditary angioedema long-term prophylaxis (HELP) study, which it said was the largest randomised controlled prevention study conducted to date in HAE, evaluating the efficacy and safety of subcutaneously administered lanadelumab compared to placebo over 26 weeks in 125 patients 12 years of age or older with HAE.Lanadelumab was previously granted accelerated assessment by the EMA, reducing the number of evaluation days required from 210 to 150.The CHMP's positive opinion would be reviewed by the European Commission, which had the authority to grant marketing authorisation in the EU.Lanadelumab received approval for the prevention of HAE attacks in patient 12 years and older in the United States on 23 August, and Canada on 19 September, under the brand name 'TAKHZYRO'.