Navigation Links
FDA Confirms Orphan Drug Exclusivity Approval for wilate®, Octapharma USA's New Therapy for Common Inherited Bleeding Disorder

HOBOKEN, N.J., Aug. 2 /PRNewswire/ -- Octapharma USA has received confirmation of orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for wilate® (von Willebrand Factor/Factor VIII Concentrate, Human), the replacement therapy developed specifically for von Willebrand Disease (VWD). The approval comes from the FDA Office of Orphan Products Development, which helps to advance the development of products that demonstrate promise for the treatment of rare diseases.

"In awarding orphan drug exclusivity, the FDA Office determined that wilate® offers greater viral safety than Humate-P," said Flemming Nielsen, President of Octapharma USA, the rapidly growing U.S. division of Octapharma AG, one of the world's largest human protein products manufacturers. "wilate® has received seven years of marketing exclusivity as a result of the evidence suggesting wilate® is as efficacious and safer than Humate P."

The FDA has approved wilate® for the treatment of spontaneous or trauma-induced bleeding episodes in patients with severe VWD as well as in patients with mild or moderate forms of the illness in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

wilate® is the first double virus inactivated VWF/FVIII (von Willebrand Factor / Factor FVIII), high-purity concentrate, utilizing the solvent/detergent (S/D) process and a special terminal dry-heating (TDH) step. The selected purification processes isolates the VWF/FVIII complex under highly protein-protecting conditions, resulting in a 1:1 ratio of VWF:RCo (ristocetin cofactor) to FVIII activity that is similar to normal plasma. No albumin is added as a stabilizer. wilate® is exclusively derived from large pools of human plasma collected in U.S. FDA approved plasma donation centers.  wilate® contains a VWF triplet structure and VWF mulitmeric distribution similar to normal human plasma.

According to the National Institutes of Health, VWD is the most common inherited bleeding disorder and occurs in about 1 out of every 100 to 1,000 people. "The FDA orphan drug exclusivity approval for wilate® confirms Octapharma's decision to focus exclusively on the treatment of von Willebrand patients and further demonstrates Octapharma's commitment to the continued advancement of human protein therapies," said Nielsen.

For more information on wilate®, please visit

About the Octapharma Group

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for over 27 years. Octapharma's core business is the development, production and sale of high quality human protein therapies from both human plasma and human cell-lines, including immune globulin intravenous (IGIV). In the U.S., Octapharma's IGIV product, octagam® (immune globulin intravenous [human] 5%), is used to treat disorders of the immune system, and Octapharma's albumin (Human) is indicated for the restoration and maintenance of circulating blood volume. Octapharma's wilate® received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for the treatment of von Willebrand disease (VWD). Octapharma employs over 4,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, N.J.  Octapharma operates two state-of-the-art production sites licensed by the FDA, providing a high level of production flexibility. For more information, please visit

Forward-looking statements

This news release contains forward-looking statements, which include known and unknown risks, uncertainties and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and actions by the FDA or other regulatory authorities.

SOURCE Octapharma USA
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Confirms Limited Human-To-Human Spread of Avian-Flu Virus in Indonesia in 2006
2. IDM Pharma Announces Updated Phase 3 Mifamurtide (L-MTP-PE) Data Confirms Statistically Superior Overall Survival in Osteosarcoma Patients
3. Study Confirms That New Protocol Shortens the Time It Takes to Open Blocked Arteries for Heart Attack Patients
4. New Data Confirms That a Selective, Fully Human Anti-VEGF Antibody Being Developed by Peregrine is as Effective as Avastin(R) in Preclinical Cancer Models
5. FDA Confirms Seizure of Eyelash Product Was Not Prompted by Reports of Adverse Effects
6. Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy With No Dose Limiting Toxicity in Metastatic Pancreatic Cancer
7. New Study Confirms Dose-Accuracy of SoloSTAR(R) Prefilled Insulin Pen
8. AviaraDx Confirms That Combination of Two Molecular Biomarkers Improves Prediction of Disease Recurrence in Early Stage Breast Cancer Patients
9. Study Confirms That Avastin Significantly Increases Chance of Living Without Disease Progression in Metastatic Breast Cancer
10. University of Miami Team Confirms Value of Monitoring Cell-Mediated Immunity Pre- and Post-Transplant in Management of Kidney Transplant Recipients
11. New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... Global Cell Surface Testing Market: Supplier ... to their offering.  --> ... of the  "2016 Future Horizons and ...
(Date:11/26/2015)... 26, 2015 ... of the  "2016 Future Horizons and ... Drug Monitoring (TDM) Market: Supplier Shares, ... Opportunities"  report to their offering.  ... the addition of the  "2016 Future ...
(Date:11/26/2015)... , November 26, 2015 ... of the "Radioimmunoassay Market by Type ... Pharmaceutical Industry, Academics, Clinical Diagnostic Labs), Application ... Forecast to 2020" report to their ... announced the addition of the "Radioimmunoassay ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article ... of Toronto and the University of British Columbia suggested that laws requiring bicyclists to ... article explains that part of the reason for the controversial conclusion is that, while ...
(Date:11/27/2015)... ... November 27, 2015 , ... A team of Swiss doctors has ... it. Surviving Mesothelioma has just posted the findings on the website. Click here ... the cases of 136 mesothelioma patients who were treated with chemotherapy followed by EPP ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... Lizzie’s ... , The company is offering customers 10% off of their purchase of lice treatment ... treatment at full price. According to a company spokesperson. “Finding lice is a sure ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community in ... (see Table 1-1 ). More than 3.7 billion people under the age of ... 1 (HSV-1), according to WHO's first global estimates of HSV-1 infection . , "The ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... A simply ... Jones, is an interesting show that delves into an array of issues that are ... that could benefit from open dialogue, this show is changing the subjects consumers focus ...
Breaking Medicine News(10 mins):