Novo Nordisk gets US approval for TRETTEN

Novo Nordisk has received US approval for TRETTEN – a treatment for congenital factor XIII (FXIII) A-subunit deficiency.

The Food and Drug Administration has approved the product, which is the only recombinant medicine for this condition – a rare bleeding disorder that has few other treatment options.

Mads Krogsgaard, chief science officer at Novo Nordisk, commented: "Today (December 26th) 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 company said the treatment was approved after demonstrating safety and efficacy, as well as providing monthly dosing with a short infusion time.

A phase III clinical trial of 41 patients was shown to reduce the number of treatment-requiring bleeding episodes suffered.

TRETTEN is expected to become available in the US from early 2014 onwards, it has already received approval in Europe and Canada.