Navigation Links
FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
Date:8/25/2011

SILVER SPRING, Md., Aug. 25, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States have HAE.

People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, voice box, or windpipe, which may result in disfigurement, disability, or death. Swelling of the digestive tract may cause abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation.

"Firazyr provides a new option to treat acute attacks of HAE and because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

The safety and efficacy of Firazyr was demonstrated in three controlled clinical trials, with open-label extension periods, in which 225 patients received 1,076 doses of 30 mg Firazyr. The median time for patients treated with Firazyr to report onset of symptom relief was two hours compared with almost 20 hours with placebo.  

Firazyr is the third drug approved in the United States to treat HAE attacks. In October 2009 the FDA approved Berinert to treat facial and abdominal attacks of HAE, and Kalbitor was approved in December 2009 to treat acute attacks of HAE in patient
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. FDA Approves Adcetris to Treat Two Types of Lymphoma
2. FDA Approves the First Specific Treatment for Scorpion Stings
3. Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director
4. FDA Tentatively Approves Intellijects Lead Product, e-cue™
5. FDA Approves New Medicine BRILINTA™ (Ticagrelor) for Use in the US
6. FDA Approves Vaccines for the 2011-2012 Influenza Season
7. FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People
8. FDA Approves Arcapta Neohaler to Treat Chronic Obstructive Pulmonary Disease
9. FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
10. FDA Approves Lazanda® - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
11. FDA Approves First Generic Versions of the Antibiotic Levofloxacin to Treat Certain Infections
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  According to Millennium Research ... market intelligence, the United States ... device markets will expand moderately through 2022, with ... In particular, increasing interest in drug-eluting beads (DEBs) ...
(Date:1/15/2014)... , Jan. 15, 2014 Reportlinker.com ... report is available in its catalogue: ... and Technologies for Advanced Drug Delivery ... Administration http://www.reportlinker.com/p01941928/Global-Markets-and-Technologies-for-Advanced-Drug-Delivery-Systems----Focus-on-Routes-of-Administration.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Delivery_Technology ...
(Date:1/14/2014)... Jan. 14, 2014 InformEx, North America,s ... high-value chemistry, will hold the 30 th edition of ... Convention Center from January 21-24. (Logo: ... top pharmaceutical, fine chemical and specialty chemical companies will take ...
Breaking Medicine Technology:US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 2US and European Transcatheter Embolization and Occlusion Device Market to Surpass $1.6 Billion by 2022 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 16Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2
... the Program in Cellular and Molecular Medicine at Boston ... (PCMM/IDI) have developed a molecular delivery platform that overcomes one ... to treat cancer: Making sure the treatment gets to the ... Lieberman , PhD, of the PCMM/IDI, and a former fellow ...
... company committed to the development of new epilepsy treatments ... data at the 64th Annual Meeting of the American ... 21-28.  The data comprise several posters examining the use ... updated health-related quality of life analysis from pooled open ...
Cached Medicine Technology:Packaging therapeutic RNAs for targeted treatment of breast cancer 2Packaging therapeutic RNAs for targeted treatment of breast cancer 3Packaging therapeutic RNAs for targeted treatment of breast cancer 4UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 2UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 3UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 4UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 5UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 6UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 7UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 8UCB Sponsors Data Presentations on Epilepsy and Vimpat® (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology 9
(Date:4/17/2014)... team has created a new technology for modifying ... travel the body and selectively target cancer and ... devices that monitor and modify human physiology is ... no existing technology enabled bioengineers to build such ... respond in a customized fashion. , "The project ...
(Date:4/17/2014)... many as 10 million older Americans suffer from depression, ... , However, new research a project that followed ... six years found that Internet use among the ... than 30 percent. , "That,s a very strong effect," ... telecommunication, information studies and media who led the project. ...
(Date:4/17/2014)... 2014 By discovering a new mechanism that allows ... researchers at UC Irvine and the Salk Institute have ... or prevent stroke-induced brain damage. , A complex and ... death and primary reason for disability in the U.S. ... and lets blood-borne material into the brain, causing the ...
(Date:4/17/2014)... (SACRAMENTO, Calif.) An international team led by researchers ... protein complex, which plays a key role in cell ... process. This is the first time the complex has ... could make cyclin B1/Cdk1 an excellent target to control ... medicine. The research was published online today in the ...
(Date:4/17/2014)... NEW YORK (17 April 2014) Population Council scientists and ... is safe, stable, and can prevent the transmission of ... and rectum in animals: HIV, herpes simplex virus 2 ... provides the first data that the gel is effective ... of efficacy in the vagina against all three viruses ...
Breaking Medicine News(10 mins):Health News:Building 'smart' cell-based therapies 2Health News:Internet use can help ward off depression among elderly 2Health News:Study IDs new cause of brain bleeding immediately after stroke 2Health News:Dual role: Key cell division proteins also power up mitochondria 2Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2
... Health and Human Services reported that very little precautionary measures ... illness (bird flu) // . The infection in humans is ... ,Hence to prevent the global pandemic it has ... occurrence of a global pandemic. The government says that ...
... Guarraci, an assistance professor of psychology at south-western university and ... has a greater effect on the sexual behaviour of female ... and is among the first to determine the effects of ... also probes into the relationship between caffeine and sex. ...
... Minister Tony Abbott told the press that all the medical expenditures ... qualified health care // personnels. ,This plan is ... But in a period of six months this plan will add ... plan will help in reducing the amount of expenditure of the ...
... donation saves hundreds of lives ever year. The need the organ, ... organ // . ,Of all the organ transplantations done, ... there is a sudden fall in the number of people who ... the waiting time of the patients to undergo kidney transplants has ...
... in London has found a unique way to help people beat ... much-needed dose of light // . ,The Dana Cafe ... winter days. ,Up to 500,000 people, a majority of ... disorder. SAD is more common in the northern latitudes where ...
... increase in its share, following approval of Vivagel by the ... // The company even signed a $20 million (US) ... Diseases, an integral part of the National Institute of Health. ... prevention of HIV infection. The FDA recognizes the potential of ...
Cached Medicine News:Health News:Starpharma Develops New Gel (Vivagel) To Prevent HIV Transmission 2
Pilling-Weck, medium clip size, 10mm, rotatable take apart...
Insert only, Ethicon, small clip size...
Ethicon, medium clip size, 10mm, rotatable take apart...
... The Wako CRP-HS assay utilizes turbidimetric ... procedure, measuring over the range of 0.2-28.0 ... can be adapted to most clinical chemistry ... performance in terms of precision, linearity, correlation, ...
Medicine Products: