Inês Martins, PhD, managing science editor —

The European Medicines Agency issued a positive opinion on BioCryst Pharmaceuticals’ application for orphan drug status of BCX7353 to treat hereditary angioedema (HAE). The European Commission is expected to adopt the recommendation from the EMA’s Committee for Orphan Medicinal Products in the next 30 days. With orphan drug designation,…

A marketing authorization application for Lanadelumab, Shire‘s investigational therapy for hereditary angioedema (HAE), was recently cleared by the Swiss Agency for Therapeutic Products (Swissmedic), the company announced. Supported by data from four clinical trials, acceptance of the marketing authorization application signals that the formal review process of the…

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…

The U.S. Food and Drug Administration (FDA) will review Shire’s application requesting that Cinryze (C1 esterase inhibitor [human]) be approved for the prevention of hereditary angioedema attacks in children 6  years and older. The supplemental biologics license application (sBLA) received priority review, meaning the process will be shortened from the standard 12 months…

  The application requesting that lanadelumab be reviewed with priority as a new treatment for the prevention of angioedema attacks has been accepted by Health Canada, the medicine’s manufacturer, Shire, announced. The New Drug Submission (NDS) is requesting the lanadelumab’s approval for patients older than 12 years, who live with hereditary angioedema (HAE). In…

The recently announced merger of BioCryst Pharmaceuticals and Idera Pharmaceuticals will strengthen the two companies’ focus on developing and commercializing treatments to serve patients with rare diseases, including angioedema, the companies said. The name of the new company has not yet been announced. Among BioCryst’s ongoing development programs is…