Navigation Links
FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
Date:2/3/2009

nts with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency. Cinryze has not been approved for acute treatment in the United States or any other jurisdiction.

Cinryze has been generally well tolerated. 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 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 unrestricted, 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 l
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
2. Chinese SFDA Grants Immtech Fast Track Status
3. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
4. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
5. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
8. FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
9. FDA Grants NeoVistas Request to Expand CABERNET Trial to 30 Sites in the U.S.
10. FDA Grants Market Clearance for the LipiScan(TM) Coronary Imaging System Developed by InfraReDx, Inc. - A Novel Spectroscopy System for the Identification of Lipid Core Containing Plaques of Interest in the Coronary Arteries
11. FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/2/2015)... , June 2, 2015 ... defines and segments the concerned market with analysis ... at $261.8 million in 2014, and is estimated ... CAGR of 19.3% from 2014 to 2019. ... Mannequin-Based Simulation Market for an analysis of industry ...
(Date:6/2/2015)... -- Intarcia Therapeutics, Inc. today announced the ... announced synthetic royalty / equity convert financing, bringing the ... Convertible Limited Recourse Notes from Intarcia and are entitled ... future global net sales of ITCA 650 until the ... the option, commencing upon U.S. regulatory approval of ITCA ...
(Date:6/2/2015)... 2015 ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ... from the U.S. Food and Drug Administration (FDA) of ... Oral Solution 5mg/5mL. Trailing twelve-month sales for the product ... competitors. ANI expects to begin shipping to its customers ... and CEO of ANI Pharmaceuticals, stated, "This ANDA represents ...
Breaking Medicine Technology:North America Mannequin-Based Simulation Market is Expected to Reach $632.5 Million by 2019, at a CAGR of 19.3% From 2014 to 2019 2North America Mannequin-Based Simulation Market is Expected to Reach $632.5 Million by 2019, at a CAGR of 19.3% From 2014 to 2019 3Intarcia Exercises Re-Opener For Its Recently Closed Royalty / Equity Convert Financing - Raising Total To $300 Million 2Intarcia Exercises Re-Opener For Its Recently Closed Royalty / Equity Convert Financing - Raising Total To $300 Million 3ANI Pharmaceuticals Announces FDA Approval of Oxycodone Hydrochloride Oral Solution 5mg/5mL 2ANI Pharmaceuticals Announces FDA Approval of Oxycodone Hydrochloride Oral Solution 5mg/5mL 3
... YORK, Sept. 15 Otherwise known as ED, ... to obtain or maintain an erection for satisfactory sexual ... the United States and occurs most frequently in men ... heart disease, vascular disease and neurological diseases. However, according ...
... Broadspire, a Crawford Company (NYSE: CRDA ; ... services provider, is proud to announce that Gary Anderberg, Ph.D., ... winner of Risk & Insurance magazine,s 2010 Risk ... as a leader with Broadspire,s e-Triage system, which helps analyze ...
Cached Medicine Technology:Men's Sexual Health and Medical Talk Show Expert Dr. Ridwan Shabsigh, MD Talks About How Erectile Dysfunction Affects Quality of Life 2Men's Sexual Health and Medical Talk Show Expert Dr. Ridwan Shabsigh, MD Talks About How Erectile Dysfunction Affects Quality of Life 3Broadspire's Gary Anderberg Named Risk Innovator of the Year 2Broadspire's Gary Anderberg Named Risk Innovator of the Year 3
(Date:6/2/2015)... 2015 Aidan Booth And Steve ... public yesterday, and has since received rave reviews ... reviewer Tiffany Hendricks has weighed in with her ... course on her website HonestyFirstReviews.com. , "These days ... marketers looking to hone their business skills has ...
(Date:6/2/2015)... 2015 On Wednesday, May 27, 2015, professional ... a top speed of 207.9 mph. In the process, ... break the 200 mph mark. Jay Leno was on ... episode of Jay Leno’s Garage, which will air on CNBC ... 8.5 mile high speed oval at the Continental Tire Proving ...
(Date:6/2/2015)... (PRWEB) June 02, 2015 UCLA Health ... of intent to partner and expand urgent care services ... to approval by the University of California Board of ... transaction will allow UCLA Health to purchase a minority ... Beverly Hills, Calabasas, Newbury Park and Northridge and creates ...
(Date:6/2/2015)... King of Prussia, PA (PRWEB) June 02, 2015 ... Business Process Outsourcing solutions for health plans in the ... announces their participation as a sponsor and exhibitor at ... trade group, America’s Health Insurance Plans. The conference will ... TMG Health exhibition booth, #1303, will offer opportunities for ...
(Date:6/2/2015)... On October 1, 2015 the transition to ICD-10 ... , On Monday, June 1st Congressman Kevin Brady, ... and Means Committee, and 12 members of the Committee ... Services, urging the administration to provide a smooth transition ... is the newest coding system for healthcare professionals to ...
Breaking Medicine News(10 mins):Health News:100K Factory - Review of Aidan Booth and Steve Clayton's New IM System Published 2Health News:774 HP Hennessey Mustang Tested to 207.9 mph 2Health News:UCLA Health Partners With Exer - More Than Urgent Care 2Health News:TMG Health to Sponsor and Exhibit at AHIP’s Institute 2015 2Health News:HomeTown Health Launches a “100 Day Countdown” in Response to ICD-10 Survey 2Health News:HomeTown Health Launches a “100 Day Countdown” in Response to ICD-10 Survey 3Health News:HomeTown Health Launches a “100 Day Countdown” in Response to ICD-10 Survey 4
... even when athletes mistakenly thought they were taking growth ... -- When athletes think they are taking a performance-enhancing ... if they never really take the drug. , So ... received human growth hormone supplements while the other half ...
... US primary care physicians,Novartis earns the highest sales ... Sanofi-Aventis, according to new,research from TNS Healthcare. Novartis ... consistent ability to build strong physician relationships.,Though Pfizer ... has,greater variability in Europe, while Merck,s European performance ...
... ROSWELL, Ga., June 17 Kimberly-Clark Professional is,donating ... Columbus, Ind.,businesses and residents clean up from the ... know that Columbus was hit very hard by ... Barfoot, Vice President of,Kimberly-Clark Professional, North America. "At ...
... June 17 ,Shire Limited (LSE: SHP, Nasdaq: SHPGY), ... of data from a,randomized, long-term safety and tolerability ... (mesalamine). The primary endpoints,of this study were to ... UC patients over 12 months. Data were published ...
... more readily than a commonly used colorectal cancer drug ... but with fewer side effects, MIT researchers have found. ... anticancer agent, but the newly investigated compound, known as ... body tissues from damage. , "This compound, the antitumor ...
... extremely rare condition. There is no definitive treatment for ... intervention, especially endoscopic treatment has recently been used and ... Dr. TH Kim and his colleagues from the Gyeongsang ... the World Journal of Gastroenterology. , Blunt abdominal trauma, ...
Cached Medicine News:Health News:Sports Doping's Effect May Be in the Mind 2Health News:Sports Doping's Effect May Be in the Mind 3Health News:Sports Doping's Effect May Be in the Mind 4Health News:Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services 2Health News:Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services 3Health News:Novartis, Pfizer and Merck Take the Lead on Strong Relationships with Physicians, as Doctors Demand an Expanding Set of Services 4Health News:Long-Term Safety Data on Lialda(TM) (mesalamine) for Patients With Ulcerative Colitis Published in Leading GI Journal 2Health News:Long-Term Safety Data on Lialda(TM) (mesalamine) for Patients With Ulcerative Colitis Published in Leading GI Journal 3Health News:Long-Term Safety Data on Lialda(TM) (mesalamine) for Patients With Ulcerative Colitis Published in Leading GI Journal 4Health News:Long-Term Safety Data on Lialda(TM) (mesalamine) for Patients With Ulcerative Colitis Published in Leading GI Journal 5Health News:Long-Term Safety Data on Lialda(TM) (mesalamine) for Patients With Ulcerative Colitis Published in Leading GI Journal 6Health News:MIT researchers see alternative to common colorectal cancer drug 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... 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 ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... 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 ...
Medicine Products: