FDA OKs drug to treat bleeding disorder

April 30, 2007

The U.S. Food and Drug Administration has approved Humate-P for the treatment of a specific bleeding disorder called von Willebrand disease.

Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) was approved for prevention of excessive bleeding during and after surgery in certain patients with mild to severe von Willebrand disease, or vWD. The disease is the most common inherited bleeding disorder, affecting about 1 percent of the U.S. population.

Humate-P is the second biological product to be approved for the management of surgery and invasive procedures in patients with vWD in whom the medication desmopressin might not work. The first biological product, Aphanate, was approved by FDA in February. However, FDA officials said Humate-P is the first product specifically for patients with severe vWD who are undergoing major surgery.

Humate-P is manufactured by CSL Behring GmbH, located in Marburg, Germany.

Copyright 2007 by United Press International

Explore further: Genetic mutation in extended Amish family in Indiana protects against aging and increases longevity (Update)

Related Stories

Genetic mutation in extended Amish family in Indiana protects against aging and increases longevity (Update)

November 15, 2017
The first genetic mutation that appears to protect against multiple aspects of biological aging in humans has been discovered in an extended family of Old Order Amish living in the vicinity of Berne, Indiana, report Northwestern ...

Study consistent with trial results for dabigatran and warfarin in atrial fibrillation

November 13, 2017
A study of two medications that can reduce risk of ischemic stroke in people with atrial fibrillation showed that outcomes in typical patients with atrial fibrillation align well with those seen in clinical trials. The findings ...

Mature B lymphocytes accelerate the healing of diabetic ulcers, other skin injuries

October 25, 2017
A Massachusetts General Hospital (MGH) research team has found a surprising potential solution to a persistent clinical problem - the healing of chronic wounds. In their report published in Wound Repair and Regeneration, ...

Trastuzumab treatment need not delay breast reconstruction following mastectomy

October 3, 2017
Treatment with trastuzumab (Herceptin/Genentech) of breast cancers that express the HER-2 protein does not increase the risk for complications at the surgical site for women who undergo immediate breast reconstruction after ...

Synthetic version of popular anticoagulant poised for clinical trials

September 6, 2017
A synthetic version of low molecular weight heparin is poised for clinical trials and development as a drug for patients with clotting disorders, and those undergoing procedures such as kidney dialysis, heart bypass surgery, ...

US approval for bleeding disorder drug

December 21, 2015
"VONVENDI [von Willebrand factor (Recombinant)]", the new drug from Baxalta Incorporated, a global biopharmaceutical company recently spun off from Baxter International, has just been approved by the United States Food and ...

Recommended for you

Sensor-equipped pill raises technological, ethical questions

November 17, 2017
The first drug with a sensor embedded in a pill that alerts doctors when patients have taken their medications was approved by the Food and Drug Administration, raiding issues involving privacy, cost, and whether patients ...

New painkillers reduce overdose risk

November 16, 2017
Scientists on the Florida campus of The Scripps Research Institute (TSRI) have developed new opioid pain relievers that reduce pain on par with morphine but do not slow or stop breathing—the cause of opiate overdose.

Separating side effects could hold key for safer opioids

November 16, 2017
Opioid pain relievers can be extremely effective in relieving pain, but can carry a high risk of addiction and ultimately overdose when breathing is suppressed and stops. Scientists have discovered a way to separate these ...

US regulators approve first digital pill to track patients

November 14, 2017
U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

Introduction is different, but top medications for opioid addiction equally effective

November 14, 2017
With opioid addiction officially declared a public health emergency in the U.S., medical intervention to treat the illness is increasingly important in responding to the epidemic. Now, a new study concludes that two of the ...

Drugstore pain pills as effective as opioids in ER patients

November 7, 2017
Emergency rooms are where many patients are first introduced to powerful opioid painkillers, but what if doctors offered over-the-counter pills instead? A new study tested that approach on patients with broken bones and sprains ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.