Mar 19 2010
ViroPharma Incorporated (Nasdaq: VPHM) today announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy.
Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against hereditary angioedema (HAE) attacks in adults and adolescents. Cinryze is not approved in the European Union or any of its member states.
"We are honored to be presenting HAE data at this important meeting," commented Peter Wijngaard, senior director, clinical development and European medical affairs, ViroPharma Europe. "ViroPharma is committed to raising awareness of HAE and educating healthcare professionals that may not have had any experience diagnosing and treating this rare disease."
The following abstracts from studies supported by Lev Pharmaceuticals, now ViroPharma Biologics, Inc., a fully-owned subsidiary of ViroPharma, were presented:
Poster Session 22: Phase 3 Results of Cinryze as Prophylactic and Acute Treatment of HAE
- In an abstract entitled, 'Safety and Efficacy of Nanofiltered C1 Inhibitor Concentrate for Acute and Prophylactic Treatment of Hereditary Angioedema due to C1 Inhibitor Deficiency,' Dr. Joshua Jacobs described two double-blind randomized placebo-controlled multi-center studies to determine the efficacy and safety of nanofiltered C1 inhibitor (C1-INH; Cinryze);
- One trial evaluated prophylactic treatment with C1-INH to prevent attacks. The second trial examined the use of C1-INH for the treatment of acute attacks of hereditary angioedema due to C1 inhibitor deficiency;
- Cinryze is not approved for acute attacks of HAE.
Poster Session 23: Prophylactic Therapy Considerations in Hereditary Angioedema
- In an abstract entitled, 'When Should Prophylactic Therapy be Considered for Hereditary Angioedema?', Dr. Richard Gower described how a literature review, guideline analysis from other countries, an expert panel meeting, and consensus development were conducted in order to develop therapy considerations for prophylaxis of HAE in the U.S.;
- The abstract suggested that patients with frequent HAE attacks, severe attacks, past laryngeal attacks, excessive loss of work or school, significant anxiety and poor quality of life could be considered for prophylaxis therapy, especially for those that fail, are intolerant, have adverse events or are not candidates for androgens;
- This abstract was the result of a consensus group on the treatment considerations for patients with HAE, which was paid for and organized by Lev Pharmaceuticals.
SOURCE ViroPharma Incorporated