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:5/26/2016)... ... May 26, 2016 , ... OncLive® ... added National Cancer Institute-designated University of Virginia (UVA) Cancer Center to ... OncLive’s editorial and marketing teams will publicize and promote public awareness of UVA ...
(Date:5/26/2016)... ... 26, 2016 , ... Workrite Ergonomics announced today that Phil ... develop their rapidly expanding portfolio of customer and end user accounts. ... and an M.B.A. with concentration in management from Bryant University in Smithfield, Rhode ...
(Date:5/26/2016)... ... , ... Dr. LeRoy Perry’s recently authored whitepaper, “Tech Neck and ROI (return ... of users, hundreds of millions of whom are coming into the workplace with pain ... common action of looking down at hand-held technology devices (tablets, smartphones) for extended periods ...
(Date:5/26/2016)... CA (PRWEB) , ... May 26, 2016 , ... In ... him running plumbing calls throughout the beach community. His vision to grow the company ... rates and ensuring they maintain the highest level of training and customer service. Over ...
(Date:5/26/2016)... ... May 26, 2016 , ... TopConsumerReviews.com ... Blood Pressure products . , High blood pressure affects millions of people worldwide, ... blood pressure can lead to heart disease, stroke, kidney disease, and hardening of ...
Breaking Medicine News(10 mins):
(Date:5/23/2016)... According to a new ... Product (Wheelchair, Scooters, Medical Beds, Bathroom Safety, Mechanical, ... Wound), Accessories (Lifting, Transfer) & by End User ... MarketsandMarkets, the patient handling equipment market is expected ... a CAGR of 10.5% during the forecast period ...
(Date:5/23/2016)... , May 23, 2016 Diplomat Pharmacy, Inc. ... annual Fellowship and Internship programs. The hands-on learning experience ... The full-time, paid Fellowship and ... Michigan . Fellows and interns are provided optional ... Flint at the Riverfront Residence Hall ...
(Date:5/23/2016)... , May 23, 2016 ... Size, Share, Development, Growth and Demand Forecast to ... and Other), by Application (Drug Discovery and Development, ... Users (Pharmaceuticals, Life Science and Biotechnology, Academic and ... Market Research, the global mass spectrometry market ...
Breaking Medicine Technology: