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Orphan Drugs: FDA Approval of Baxter’s Treatment For Rare Form of Hemophilia

October 24, 2014

On October 24th, the FDA announces the approval of Baxter International’s orphan drug Obizur [Antihemophilic Factor (Recombinant), Porcine (pig) Sequence] for the treatment of bleeding episodes in adults with Acquired Hemophilia A (AHA) (acquired Factor VIII [FVII] deficiency).

AHA is a rare bleeding disorder,

“ … caused by the development of antibodies (immune system proteins) directed against the body’s own FVIII, a protein important for blood clotting … blood doesn’t clot normally, resulting in excessive bleeding … Unlike inherited hemophilia, AHA is not a genetic disorder and affects both males and females …”.

According to Baxter International’s Press Release, Obizur will be commercially available in the US in the coming months and is currently under regulatory review in Europe and Canada.

The approval comes a month (September 2014) after Baxter International announces Baxalta as the name of the new global biopharmaceutical company spin-off that is expected to launch in mid-2015. Upon completion of the separation, Baxalta plans to trade on the New York Stock Exchange (NYSE) under the symbol BXLT. Baxter International will continue trading on the NYSE under the symbol BAX. Baxalta will have approximately $6 billion in global revenues and will provide treatments for rare and chronic conditions, including Hemophilia and other bleeding disorders. The Baxalta logo will be unveiled at a later date.

According to Ludwig Hantson, Ph.D., President of Baxter BioScience:

“The name Baxalta celebrates and sustains Baxter’s heritage as an innovator with a legacy of leadership by incorporating the Baxter name and coupling it with ‘alta,’ which derives from altus, Latin for ‘high’ or ‘profound.’  Both companies share a deep commitment to meeting the needs of current and future patients, which will continue to inspire us going forward.”

Please Note: FDA Official Logo from FDA website.

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