FDA Accepts Shire’s BLA and Grants Priority Review for Lanadelumab

Shire (NASDAQ: SHPG) announced the U.S. Food and Drug Administration accepted the Biologics License Application and granted priority review 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.

As quoted in the press release:

“Every day, patients living with HAE struggle to manage their disease – not knowing when their next attack will occur,” said Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire. “Lanadelumab if approved will be the first monoclonal antibody for HAE, a serious and potentially life threating disease. Lanadelumab provides a new mechanism of action inhibiting plasma kallikrein for the prevention of HAE attacks. Lanadelumab will offer patients a new option to help control this disease with the potential to change the treatment paradigm. The FDA’s decision underscores Shire’s serial innovation in HAE and commitment to improving treatment options for patients.”

Click here to read the full press release.