Shire: CHMP Recommends EU Marketing Authorisation of lanadelumab for the Prevention of HAE Attacks

Shire (LSE:SHP, NASDAQ:SHPG), the leading global biotechnology company focused on rare diseases, announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorisation of lanadelumab injection for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

As quoted in the press release:

HAE is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide.2^,3 The condition results in recurring attacks of oedema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat, that can be debilitating and painful. Laryngeal attacks that obstruct the airways are potentially life-threatening due to the risk of asphyxiation.^2,4,5

“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 Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire. “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 positive opinion is supported by data from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study™, the largest randomised controlled prevention study conducted to date in HAE, which evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo over 26 weeks in 125 patients 12 years of age or older with HAE.

Click here to read the full press release.