The European Medicines Agency (EMA) has granted an accelerated assessment for Lanadelumab (SHP643), an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with HAE.
“The EMA decision, coupled with the U.S. FDA’s recent Priority Review designation for Lanadelumab, reinforces Shire’s dedication to advancing new treatment options for patients suffering from HAE,” said Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire. “As the first investigational monoclonal antibody being studied in HAE, Lanadelumab utilizes a novel mechanism of action inhibiting plasma kallikrein for the prevention of HAE attacks. We look forward to further progressing Lanadelumab through the regulatory review process, as we strive to bring new and innovative solutions to the patients who need them most.”
Shire is on track to submit its EU Marketing Authorization Application (MAA) in the coming weeks. Accelerated assessments by the CHMP of a marketing authorization filed under the centralized European procedure, reduces the number of evaluation days required, from 210 to 150. The EMA will grant, upon request, accelerated assessment of an EU MAA if they deem the product to be of major interest for public health and therapeutic innovation.
“I’m excited to see Lanadelumab receive an accelerated assessment in Europe because we are one step closer to potentially having a new option to help prevent HAE attacks,” said Marcus Maurer, Prof. Dr. Med., Department of Dermatology and Allergy, Charité – Universitätsmedizin Berlin, Germany, and clinical trial investigator. “As an investigator, I want to express my gratitude to the HAE patients and their families who participated in the clinical trial and the dedicated study site personnel, who have helped to advance science in a way that may transform the treatment of HAE.”