Navigation Links
ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
Date:12/1/2008

EXTON, Pa., Dec. 1 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze(TM) C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE).

The sBLA is based on a re-analysis and resubmission of data from a pivotal Phase 3 acute treatment study of Cinryze and interim data from an ongoing open label acute study of the drug. The administration of Cinryze was effective in treating acute HAE attacks in these studies. The safety profile was similar to that observed with the use of Cinryze for routine prophylaxis of angioedema attacks in patients with HAE, the currently approved claim. Overall, more than 9,000 doses of Cinryze have been administered to over 180 patients in all controlled and open label clinical studies of Cinryze for both acute treatment and routine prophylaxis against angioedema attacks.

The Phase 3 acute treatment study was a randomized, double blind, placebo controlled multi-center trial in 71 patients evaluating the safety and efficacy of Cinryze for treatment of HAE attacks. The primary efficacy measure in the pivotal Phase 3 acute treatment study was the time from initial treatment to the start of unequivocal relief of the defining symptom. Based on the primary efficacy variable, in the All Randomized (ITT) Dataset, the likelihood of a patient having the start of unequivocal relief of the defining symptom was 2.048 times greater in the Cinryze treatment group than in the placebo treatment group (p=0.048). The median time to the start of unequivocal relief of the defining symptom was shorter in subjects in the Cinryze treatment group (two hours) than in subjects in the placebo treatment group (greater than four ho
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. ViroPharma To Present At The 20th Annual Piper Jaffray Healthcare Conference
2. ViroPharma to Discuss Commercialization and Launch of Cinryze(TM) on November 5, 2008
3. ViroPharma Incorporated Reports Third Quarter 2008 Financial Results
4. ViroPharma to Release 2008 Second Quarter Financial Results on July 30, 2008
5. ViroPharma Incorporated Reports First Quarter 2008 Financial Results
6. ViroPharma Incorporated Reports Fourth Quarter and Full Year 2007 Financial Results
7. Vincent J. Milano to Succeed Michel de Rosen as President and Chief Executive Officer of ViroPharma
8. ViroPharma Provides Update on Vancocin(R)
9. ViroPharma Augments Senior Management
10. ViroPharma to Present at the 26th Annual JP Morgan Healthcare Conference
11. ViroPharma Receives European Orphan Drug Designation for CAMVIA(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/20/2014)... TX (PRWEB) September 20, 2014 ... Forecast and Market Analysis to 2023?. The asthma ... decade, as it has become saturated with relatively ... inhaled corticosteroids (ICSs), inhaled corticosteroids and long-acting beta-agonists ... facing increasing generic competition. However, the launch of ...
(Date:9/20/2014)... September 20, 2014 Recently, Best ... site, has launched its new website. The new ... of popular hosting products for customers. Here, people ... make a purchasing decision. Also, it has recommended ... , One of the great web hosting ...
(Date:9/20/2014)... "As a nurse, patients always ask me how much ... Tamaqua, Pa. "The reason that they cannot tell is because ... My invention enables them to check oxygen levels on their ... it easier to monitor the contents of an oxygen tank. ... is low. It allows changeovers to be performed under optimal ...
(Date:9/20/2014)... (PRWEB) September 20, 2014 Earlier this week, ... customers may have had their credit card information pilfered by ... spawning a slew of headline articles like this one ... the only eye opening numbers. , “Most people tend ... almost like it’s a way to score a game,” says ...
(Date:9/20/2014)... Final Cut Pro X Plugin developers ... Information theme for FCPX filmmakers. , “Fun, cool, and simple ... theme,” says Christina Austin, CEO of Pixel Film Studios. “It ... Information features easy to use controls that give the user ... the background color, color of each circle outline, the position ...
Breaking Medicine News(10 mins):Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 2Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 3Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 4Health News:Best Cheap Hosting USA Launches Its New Website And Recommends InMotion To Worldwide People 2Health News:Don’t Let Data Breach Fatigue Cause Dangerous Cyber Security Complacency 2Health News:Don’t Let Data Breach Fatigue Cause Dangerous Cyber Security Complacency 3Health News:Don’t Let Data Breach Fatigue Cause Dangerous Cyber Security Complacency 4Health News:Don’t Let Data Breach Fatigue Cause Dangerous Cyber Security Complacency 5Health News:Today Pixel Film Studios Announced the Release of the Information Theme for Final Cut Pro X 2
... Systems Using New Software That Enables SPECT Procedures ... That Meet New ASNC Technology Standards, ... a leading provider of diagnostic imaging systems and,services to physicians, ... from the U.S. Food and Drug,Administration (FDA) 510(k) clearance for ...
... Enhance Computer Security, ATLANTA, Sept. 22 ... has published the locations,of the computers, from which ... its clients in 2008. The United States topped ... computers within the,country and China ran second with ...
... to eat tomatoes this summer and when tomatoes were vindicated, ... safety expert says there is only so much that can ... "We basically want perfect food, but produce is not sterile," ... MU College of Agriculture, Food and Natural Resources. "We all ...
... Stern + Associates (S+A), the,rapidly growing, full-service ... New Jersey with offices in Cambridge,Mass., has added ... Corporation and the Pain Control product area of ... expanded its public relations,programming for Bracco Diagnostics Inc. ...
... Healthcare’s announcement that it will discontinue several key anesthesia ... to Ohmeda customers. , ... ... DRE, Inc., a premier international http://www.dremed.com [surgical ...
... demonstrating significant effect of new, formulation of Rebif(R) on disease activity ... ... -- Data presented at late-breaking session of the World Congress on ... GENEVA, Sept. 22 Merck Serono, a division of Merck,KGaA, Darmstadt, Germany, ...
Cached Medicine News:Health News:Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time With Less Radiation 2Health News:Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time With Less Radiation 3Health News:Compromised US and Chinese Computers Launch Greatest Number of Cyber Attacks, According to SecureWorks' Data 2Health News:Compromised US and Chinese Computers Launch Greatest Number of Cyber Attacks, According to SecureWorks' Data 3Health News:Is the salad bar safe? Produce concerns linger after summer scares 2Health News:Stern + Associates Signs New Clients to Health Care Practice 2Health News:DRE Medical Equipment Offers Valuable Discounts to GE Healthcare Customers 2Health News:Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple Sclerosis 2Health News:Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple Sclerosis 3Health News:Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple Sclerosis 4Health News:Results From IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif(R) at 16 Weeks in Patients With Multiple Sclerosis 5
(Date:9/19/2014)... 19, 2014  4WEB Medical announces the formal launch ... ankle osteotomy implants on the market today at ... meeting in Chicago .  The Osteotomy ... osteotomy needs with 74 size options included in one ... of only 15 to 18 implant sizes, which limited ...
(Date:9/19/2014)... Merck (NYSE: MRK ), known as MSD ... Canada , is teaming with celebrity chef and cookbook author ... , an educational program encouraging Hispanics with type 2 diabetes to ... goal to help reduce the risk of serious health problems. Hispanics ... higher risk for developing type 2 diabetes than non-Hispanic white adults, ...
(Date:9/19/2014)... 2014  Diplomat, the nation,s largest independent specialty pharmacy, ... to the Board of Directors on September 15, 2014. ... serve as chair of the Audit Committee. ... financial, compliance and operating experience in the health care ... chief financial officer, chief operating officer and secretary of ...
Breaking Medicine Technology:4WEB Medical Unveils 3D-Printed Osteotomy Truss System 2Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 2Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 3Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 4Celebrity Chef Leticia Moreinos Schwartz Partners with Merck on Desafiando La Diabetes: Logra Tus Metas to Urge Hispanics With Type 2 Diabetes to Get to Their A1C Goal 5David Dreyer Appointed to Diplomat Board of Directors 2
... AVIV, Israel , June 29, 2010 ... invasive, accurate,diagnosis of heart diseases, announced today that its ... intended for,improved diagnostic performance of Stress ECG, has been ... is an add-on system with the,HyperQ technology which is ...
... ,, NEW YORK , ... the "Company") (NYSE Amex: NBS ), an international ... , announced on June 15, 2010 that ... government,inspection by the State Food and Drug Administration ("SFDA") ...
Cached Medicine Technology:BSP Granted CE Mark for its HyperQ AD-100 Product Enabling Improved Diagnostic Performance of Stress ECG 2NeoStem Pharmaceutical Subsidiary Announces Two cGMP Lines are Now Fully Operational in New Facility 2NeoStem Pharmaceutical Subsidiary Announces Two cGMP Lines are Now Fully Operational in New Facility 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: