FDA to Give Priority Review to Hereditary Angioedema Therapy Lanadelumab

The U.S. Food and Drug Administration plans a priority review of lanadelumab, Shire’s kallikrein inhibitor to prevent hereditary angioedema swelling attacks. Shire is asking for the therapy’s approval for patients aged 12 and older. Priority review means the FDA must make its final decision on Shire’s Biologics License Application in…

Shire to Seek FDA Marketing Approval for Lanadelumab as Therapy for Hereditary Angioedema

The biopharmaceutical company Shire is expected to soon submit a biologics license application to the U.S. Food and Drug Administration (FDA) seeking marketing approval of its investigational monoclonal antibody lanadelumab as therapy for patients with hereditary angioedema. The application is supported by positive results from the company’s Phase 3 HELP…