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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.
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"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
Poster Session 23: Prophylactic Therapy Considerations in Hereditary Angioedema
About Cinryze(TM) (C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.
The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving high dose off-label C1 inhibitor therapy well above the approved treatment dosage regimen. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening patients for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an injection rate of 1 mL per minute.
About Hereditary Angioedema (HAE)
HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unregulated, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Patients with HAE experience approximately 20 to 100 days of incapacitation per year. There are estimated to be at least 6,000 people with HAE in the United States.
For more information on HAE, visit the U.S. HAE Association's website at: http://www.haea.org/.
About ViroPharma Incorporated
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing innovative products for physician specialists to enable the support of patients with serious diseases for which there is an unmet medical need, and providing rewarding careers to employees. ViroPharma commercializes Cinryze(TM) (C1 esterase inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information on ViroPharma's commercial products, please download the package inserts at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including C1 esterase inhibitor deficiency and C. difficile.
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, http://www.viropharma.com/. The company encourages investors to consult these sections for more information on ViroPharma and our business.
-- 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.
SOURCE ViroPharma Incorporated
