Skip to content

Orphan Drugs: Biogen Idec Receives FDA Approval

March 29, 2014

Biogen Idec announces on March 28th that the FDA approves orphan drug Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein), for use in children and adults with Hemophilia B. It is the first long-acting recombinant coagulation Factor IX concentrate for Hemophilia B. Alprolix is made up of the Factor IX molecule linked to a protein fragment Fc (found in antibodies), which makes the product last longer in circulation. This results in less frequent injections for patients. According to Biogen Idec, “Alprolix is the first significant advance in Hemophilia B treatment in more than 17 years”.

Hemophilia B, which affects approximately 4,000 people in the United States and 28,000 worldwide, is an inherited sex-linked blood clotting disorder affecting mostly males. It is caused by defects in the Factor IX gene.

Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialization of Alprolix. Biogen Idec has manufacturing and commercialization rights in North America and all other regions in the world excluding Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe, Russia, the Middle East and Northern Africa.

References

Biogen Idec Press Release

FDA News Release.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2014, Orphan Druganaut Blog . All rights reserved.

Advertisements
Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: