Navigation Links
FDA Approves Xiaflex for Debilitating Hand Condition

SILVER SPRING, Md., Feb. 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person's ability to straighten and properly use their fingers.


Dupuytren's contracture affects the connective tissue found beneath the skin in the palm of the hand.  Too much collagen can build up, forming thick, rope-like cords of tissue that can prevent the fingers from being able to relax and straighten normally.  The disorder is most common in Caucasians and in men over age 50.

Xiaflex is a biologic drug made from the protein product of a living organism. It works by breaking down the excessive buildup of collagen in the hand.

"Before the FDA approved Xiaflex, the only effective treatment for this hand disorder was surgery, which sometimes meant a long recovery and the need for physical therapy for patients. Since there are no other non-surgical alternatives for Dupuytren's contracture, Xiaflex will be an important advance in the management of this disabling condition," said Bob Rappaport, M.D., director, Division of Anesthesiology, Analgesia, and Rheumatology of the FDA's Center for Drug Evaluation and Research.

Xiaflex is injected directly into the collagen cord of the hand and should be administered only by a health care professional experienced with injections of the hand, because tendon ruptures may occur.

The most common adverse reactions in patients treated with Xiaflex were fluid build up, swelling, bleeding, and pain in the injected area. Although no serious allergic reactions have been observed, such a response would not be unexpected because this foreign protein could prompt an immune system reaction.

In one 66-patient study, 44 percent of those injected with Xiaflex were treated successfully, compared to 5 percent for patients who received a placebo. In a separate 306-patient study, 64 percent of patients given Xiaflex were treated successfully, compared to only 7 percent of patients receiving the placebo.

Xiaflex is manufactured by Auxilium Pharmaceuticals Inc., a specialty biopharmaceutical company based in Malvern, Penn.  

Media Inquiries: Karen Riley 301-796-4674;

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration



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

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from reveals that behind the tendency to set low expectations is ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Marcy was in a crisis. Her son James, ... out at his family verbally and physically. , “When something upset him, he couldn’t control ... use it. He would throw rocks at my other children and say he was going ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
Breaking Medicine News(10 mins):