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Novo Receives FDA Approval for rFXIII Therapy

January 1, 2014

Last month, Novo Nordisk announced that the US Food and Drug Administration (FDA) approved TRETTEN®, the first recombinant factor XIII A-subunit therapy for the routine prophylaxis of bleeding in individuals with inherited factor XIII (FXIII) A-subunit deficiency. The new product represents the only recombinant treatment for congenital FXIII A-subunit deficiency, a rare bleeding disorder with limited treatment options. TRETTEN® demonstrated safety and efficacy in trials that incorporated a monthly dosing regimen.

Patients with congenital FXIII A-subunit deficiency are prone to bleeds, including spontaneous intracranial hemorrhaging. Caused by a lack of the protein clotting factor XIII, congenital FXIII deficiency occurs in one in three to five million births in the United States, making it the rarest of the rare bleeding disorders. It affects all ethnicities and both genders equally. According to 2011 estimates, only 1,054 patients are diagnosed worldwide, of which an estimated 108 live in the US.

"Today marks an exciting milestone for people living with congenital FXIII deficiency, and we are proud to provide a recombinant therapy to people living with this very rare disease," said Mads Krogsgaard, chief science officer, Novo Nordisk. "Through our expanding portfolio of recombinant products, we are committed to serving the hemophilia and rare bleeding disorders community."

TRETTEN® is expected to be available to US patients in early 2014. It is also approved in Canada, Australia, Switzerland and Europe under the brand name NovoThirteen®. It has also been submitted for regulatory approval in a number of other countries.

In 2011, the FDA approved Corifact, a plasma-derived product, to treat patients with FXIII deficiency.


Source: Novo Nordisk news release dated December 23, 2013