New Medicines

NovoThirteen (EU/UK), Tretten (US) Congenital factor XIII A-subunit deficiency


NovoThirteen (EU/UK), Tretten (US)
New molecular entity
Novo Nordisk
Novo Nordisk

Development and Regulatory status

July 2022
Jul 22Available in the UK. 2500 units powder and solvent for soln for inj, 1=£15918.13 [15]
Jan 21Approved in the UK for ´long term prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency´ and ´treatment of breakthrough bleeding episodes during regular prophylaxis´ [14].
Jan 17Novo Nordisk has no current plans to launch in the UK [13].
Mar 14Has been launched for Factor XIII deficiency in the US [12].
Mar 14Licence extension for use in children under the age of 6 years approved in the EU [10].
Jan 14EU positive opinion for a licence extension to include long-term prophylactic treatment of bleeding in adult and paediatric patients with congenital factor XIII A-subunit deficiency [9].
Dec 13Approved in the US for routine prophylaxis of bleeding in adults and children with congenital Factor XIII A-subunit deficiency [7]
Aug 13The FDA has issued a second complete response letter citing unresolved findings at the facility where the company manufactures the drug [6].
Mar 13Novo Nordisk expected to launch catridecacog in the first European countries towards the end of 2012 [5]
Feb 13Launched in Denmark [8].
Sep 12Approved in the EU [4].
May 12EU positive opinion for long-term prophylactic treatment of bleeding in patients 6 years and above with factor XIII A-subnunit deficiency [1].
Feb 11Filed in the US [2].


A recombinant coagulation factor XIII A-subunit. It is structurally identical to the human FXIII A-subunit [A2], the subunit of FXIII which contains the enzymatic activity, which binds to the FXIII B-subunit [A2B2].
Congenital factor XIII deficiency is an inherited bleeding disorder due to reduced levels & activity of factor XIII (FXIII) & characterised by hemorrhagic diathesis frequently associated with spontaneous abortions & defective wound healing. Factor XIII deficiency is one of the most rare coagulation factor deficiencies. Prevalence of homozygous forms is estimated at around 1 per 2,000,000. Men & women are affected equally [3].
Congenital factor XIII A-subunit deficiency

Trial or other data

Dec 10Positive results from a PIII trial in 41 pts in the US, Canada & Europe presented (NCT00713648). When compared with a historic control gp of individuals who did not receive recombinant factor XIII infusions, preventive treatment with monthly catridecacog injections significantly decreased the number of bleeding episodes requiring treatment with an additional factor XIII product (primary endpoint). Pts received intravenously administered catridecacog once every four weeks at a dose of 35 IU/kg. Over the study period, a total of five bleeding episodes, all associated with trauma and requiring additional FXIII treatment, were observed in four patients. No thromboembolic events or fatal adverse events were reported. An extension of this trial (NCT00978380) is ongoing and will continue until the product becomes available in the market. However, an interim analysis will be conducted when all subjects have completed 52 weeks in the trial [2].