EMA validates marketing authorisation application for HAE treatment

Shire has announced that the European Medicines Agency (EMA) has validated its marketing authorisation application (MAA) for lanadelumab (SHP643) for investigational Hereditary Angioedema (HAE) treatment.

Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with HAE — a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide. This validation indicates that the EMA has significant data to begin review under accelerated assessment.

“HAE presents a significant burden on the lives of patients whose recurring attacks of swelling can be debilitating and painful,” said Andreas Busch, PhD, executive vice president, head of Research and Development at Shire. “Lanadelumab is the first monoclonal antibody under evaluation to prevent HAE attacks and has the potential to change the treatment paradigm for this rare disease, if approved. We look forward to working with regulatory bodies to bring a new treatment option to HAE patients.”

“As a physician treating patients with HAE, I would welcome new treatment options to help prevent attacks, as it is important to recognise the impact HAE can have on the quality of life of these individuals,” said Marcus Maurer, Prof. Dr Med., Department of Dermatology and Allergy, Charité — Universitätsmedizin Berlin, Germany and clinical trial investigator. “I am pleased to see the progress in the review of lanadelumab, that if approved, would offer a targeted mechanism of action inhibiting plasma kallikrein.”

Furthermore, the company has announced that Health Canada has completed screening and accepted the new drug submission (NDS) under priority review for this investigational compound, has received priority review from the US Food and Drug Administration (FDA) as well as a priority review and orphan drug designation from the Therapeutic Goods Administration in Australia.