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Sunday, January 18, 2009

Exciting News From Wash DC!!!


Tremendously great news from our nation's capital. Life is about to change for a lot of people--but it's nothing to do with a new president. Finally, a product has been approved by the US FDA for those with factor I deficiency!

It's called RiaSTAP (Fibrinogen Concentrate (Human)), and it's indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (factor I deficiency), including afibrinogenemia and hypofibrinogenemia. RiaSTAP is a heat-treated, lyophilized fibrinogen powder made from pooled human plasma.

From www.businessspectator.com.au: "The approval by the FDA requires further study after marketing to confirm the product provides meaningful benefits to patients. The safety of Riastap, derived from human blood plasma, 'appears to be acceptable,' FDA reviewers said. The drug is already sold in parts of Europe as Haemocomplettan P."

For more info, check out this site:

http://www.fda.gov/cber/products/riastap.htm

From the NHF website:

"Factor I deficiency is actually a collective term for several rare inherited fibrinogen deficiencies. Fibrinogen may be absent from the blood altogether (afibrinogenemia), present in only very low levels in the blood (hypofibrinogenemia), or measurable in normal quantities but defective (dysfibrinogenemia).

"The incidence of Factor I deficiency is estimated at 1 to 2 per million. It is inherited in an autosomal recessive fashion, which means it affects men and women equally.

"Fibrinogen helps platelets to glue together to form the initial 'plug' in response to an injury. Therefore, people with factor I deficiency, have a combined bleeding disorder because both platelets and clotting are abnormal. The severity of the disorder is directly related to the amount of fibrinogen present.

"Afibrinogenemia and hypofibrogenemia are usually diagnosed in newborns who can present with head bleeds, bleeding after circumcision and from the site of the umbilical cord. Easy bruising, nose and mouth bleeds, and soft tissue bleeds are also common. Joint bleeding is relatively uncommon. Women with afibinogenemia have an increased risk of spontaneous abortion. Persons with dysfibrinogenemia may have a disposition to thrombosis."

It's great to know there is now somethign commercially avaiable for patients. This is another great from CSL Behring.
Congratulations to all!

3 comments :

Polyhymnia said...

Yes! I am one of the very few who has congenital afibrinogenemia. I am so glad to see this have finally received FDA approval.

Linda in Tallahassee, FL
http://mailmanbox.colby.edu/mailman/listinfo/fibrinogen

Laurie Kelley said...

Hi Linda, I am very happy for you. I do know two families who suffer with this. It's great news. Good luck!

Alison, Mom to Emily said...

This is so wonderful! We are so ecstatic for our little Emily and others with this disorder.

 
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