Clotting Disease Drug Tretten Approved by FDA

The U.S. Food and Drug Administration (FDA) has recently approved a new drug that helps prevent blood clots. The drug, known as Tretten, works through the involvement of a routine prophylaxis of bleeding in people with congenital factor XIII A-subunit deficiency. 

"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, according to the FDA. " Through our expanding portfolio of recombinant products, we are committed to serving the haemophilia and rare bleeding disorders community."

Tretten is the only recombiant treatment at this time for congenital FXIII A-subunit deficiency--a serious and rare bleeding disorder with limited treatment options. 

The drug's demonstrated safety and efficacy offers patients once-monthly dosing with a short infusion of time, according to the organization. 

"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 haemophilia and rare bleeding disorders community."

Based on the results from a clinical program that demonstrated the safety and efficacy of Tretten, a trial that involved 41 patients showed that Tretten injections significantly decreased the number of treatment-requiring bleeding episodes. 

The most common side-effects associated with the drug included headache, pain in the extremities, injection site pain and D-dimer increase.