ViroPharma receives European Centralized Marketing Authorization for Cinryze for treatment of HAE

Jun 16 2011

ViroPharma Incorporated (Nasdaq: VPHM) today announced that the European Commission has granted ViroPharma Centralized Marketing Authorization for Cinryze® (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema (HAE) for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.  The approval also includes a self administration option for appropriately trained patients included in the Summary of Product Characteristics (SPC).

The therapeutic indication in Europe is for treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment.

"Many patients experience frequent or severe attacks that are not only disabling and potentially fatal, but also lead to constant anxiety about when an attack will occur significantly impacting patients' ability to conduct normal and productive lives," commented Prof. Konrad Bork of the Department of Dermatology of Johannes Gutenberg University in Mainz, Germany. "The approval of Cinryze in Europe provides a very important new option to meet the needs of these severely afflicted HAE patients."

Privatdozent Wolfhart Kreuz, M.D., of the Comprehensive Care Centre (CCC) for Hereditary and Acquired Angioedema of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany added, "While it is essential that we provide therapies to treat HAE attacks, many patients require or want the ability to proactively reduce the frequency or severity of their attacks.  Cinryze is a comprehensive management option that can empower patients and physicians to seek the security and control of preventative therapy, while also treating breakthrough attacks."

HAE is a rare, debilitating and potentially life-threatening genetic disorder that affects at least 10,000 people in Europe.  HAE is a variable disease due to a deficiency of C1 inhibitor, a human plasma protein that prevents swelling. Patients can experience unpredictable, recurrent, disabling and potentially deadly attacks of swelling that can affect the larynx, abdomen, face, extremities and genitourinary tract.  Cinryze helps to control HAE by increasing functional C1 inhibitor activity. ViroPharma's Cinryze is the first and only C1 inhibitor approved on clinical data supporting its effectiveness in the prevention of attacks of this potentially dangerous genetic disease.  

"As a global HAE patient advocacy organization, HAEi welcomes new therapeutic options for our patient population in the European Union, and around the world," commented Henrik Boysen, the executive director of HAEi, the International Patient Organization for C1 Inhibitor Deficiencies. "Now, with Cinryze licensed in the EU to both prevent and treat HAE attacks, physicians and patients have another important therapeutic option to help reduce suffering."

The approval of Cinryze follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in March 2011. Cinryze is now approved throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein.

"The approval of Cinryze throughout Europe is an important milestone for ViroPharma in our evolution as an international biopharmaceutical company that delivers novel solutions that address the unmet medical needs of patients living with few, if any, clinical treatment options," commented Vincent Milano, ViroPharma's president and chief executive officer. "We are thrilled to bring this important new therapy to European HAE patients seeking a more normal life through the prevention and treatment of their attacks."  

Thierry Darcis, M.D., ViroPharma's vice president, general manager, Europe, added, "Providing for the evolving needs of patients is our priority throughout our global organization, and we look forward to working closely with physicians across Europe as we launch this product into European markets."