Navigation Links
FDA Approves New Product to Treat Von Willebrand Disease

The U.S. Food and Drug Administration (FDA) today announced the approval of Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate. //The product is approved for patients undergoing surgery or invasive procedures with von Willebrand disease (vWD) in whom the hormone desmopressin is either ineffective or contraindicated. It is not approved for patients with severe vWD (Type 3) who are undergoing major surgery. The disease is the most common inherited bleeding disorder, affecting about one percent of the U.S. population.

Alphanate is the first biologic product approved for treatment of surgical and invasive procedures in patients with vWD. Alphanate is already approved for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency.

"This approval is an important advance for patients and their surgeons, providing them access to a proven preventive therapy that can make needed surgery possible and safer," said Jesse L. Goodman, M.D., MPH, director of FDA's Center for Biologics Evaluation and Research.

Men and women are equally affected by vWD, which is caused by a deficiency or defect in certain plasma proteins critical to blood clotting. In most affected people, the disease is mild, and treatment usually is not required to stop bleeding. However, about 2,000 people in the U.S. each year suffer from moderate and severe forms of the disease in which bleeding can be excessive if not treated.

Successful management of surgery or invasive procedures in mildly, moderately and severely affected individuals routinely requires correction of the bleeding defect. In the absence of correction of the bleeding defect, patients may suffer from prolonged bleeding and delayed wound healing.

Alphanate is purified from pooled human plasma from carefully screened and tested U.S. donors, and contains the clotting proteins deficient or def ective in vWD, which are Factor VIII (also know as Antihemophilic factor) and von Willebrand factor. Alphanate undergoes two separate steps for viral inactivation to reduce the risk for transfusion-transmitted viruses. However, the potential risk for the transmission of blood-borne viruses, and theoretically variant CJD, while very low, cannot be totally eliminated.

In clinical studies with Alphanate, 120 major, moderate and minor surgical procedures were performed in 76 patients. Based on predefined criteria for efficacy, more than 90 percent of patients had favorable outcomes. In these clinical studies, 15.8 percent of subjects and 5.7 percent of infusions were accompanied by adverse reactions, most commonly itching, pharyngitis, paresthesia (a sensation of numbness and tingling on the skin) and headache, swelling of the face, and rash and chills.

Source-Bio-Bio Technology
'"/>




Related medicine news :

1. FDA Approves Contraceptive Ring
2. FDA Approves New HIV Drug, Viread
3. FDA Approves Birth Control Skin Patch
4. FDA Approves New Arthritis Drug, Bextra
5. FDA Approves Elidel Cream for Eczema
6. FDA Approves New Anti-Clotting Drug
7. FDA Approves New surgery Treatment for Farsightedness
8. FDA Approves Anti-Cancer Cell Drug - Zevalin
9. FDA Approves Remodulin for Pulmonary Hypertension
10. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
11. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset ... of specialty vendors and unique items from across the nation, this holiday-themed event will ... services offered by the VNA. The boutique will be open Saturday, November 4 ...
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released a ... books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture of ... have tossed it off as mere rubbish, but Yisrayl Hawkins says that is because ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to ... to save lost souls in the Philippines. “The Journey: From the Mountains to the ... teacher of the Bible. She has taught all ages and currently teaches a class ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... IsoComforter, Inc. ... products, announced today the introduction of an innovative new design of the shoulder pad. ... so you get maximum comfort while controlling your pain while using cold therapy. By ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... and NEW YORK , Sept. 27, 2017 ... mobile health and big data solutions, today announced that its MyDario product ... check your local TV listings for when The Dr. Oz Show airs ... The ... this month. ...
(Date:9/22/2017)... 2017 AVACEN Medical (AVACEN) announced that its ... helping those with the widespread pain associated with fibromyalgia ... in Essex, England commented, "I ... experiencing no sleep at all, tremendous pain, with every ... recommend [the AVACEN 100] enough, how this has and ...
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has ... the Atlanta Football Host Committee (AFHC) for the 2018 College ... Jan. 8, 2018, at Mercedes-Benz Stadium in Atlanta, ... of the AFHC "I,m In" campaign, participating in many activities ... ...
Breaking Medicine Technology: