The EMA Grants Accelerated Assessment for Shire’s Lanadelumab

Shire (NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment for 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).

As quoted in the press release:

“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.”

Click here to read the full press release.