Novo Nordisk granted approval for TRETTEN treatment

Novo Nordisk has been granted approval from the US Food and Drug Administration (FDA) for its TRETTEN drug, the world's first recombinant treatment for congenital FXIII A-subunit deficiency.

Patients with this condition are susceptible towards heavy bleeding and may be prone to spontaneous intracranial haemorrhage. It is caused by a lack of the factor XIII clotting protein and is estimated to occur in one in every three to five million births in the US.

Mads Krogsgaard, chief science officer at Novo Nordisk, said: "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."

The FDA approved the treatment following the results of a phase III trial of 41 individuals, which found monthly injections significantly reduced the number of bleeding episodes experienced by these patients when compared to a historic control group.

TRETTEN is now expected to be available in the US in early 2014 and has also been submitted for regulatory approval in a number of other countries.