Author Archives: Inês Martins PhD

Swiss Agency to Begin Review Process for Lanadelumab to Treat Hereditary Angioedema

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…

FDA Will Review Cinryze as Preventative for Pediatric Hereditary Angioedema Patients

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…

Health Canada Grants Priority Review of Lanadelumab as Prevention for Angioedema Attacks

  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…