Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment for Shire’s lanadelumab (SHP643).
Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with the rare, genetic disorder, hereditary angioedema (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.”
HAE is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide.1,2 The condition results in recurring attacks of edema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat that can be can debilitating and painful.1,3,4 Attacks that obstruct the airways (asphyxiation) are potentially life-threatening.
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 amount 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.