Novo Nordisk (NVO) received positive news when then U.S. Food and Drug Administration (:FDA) approved its congenital FXIII deficiency treatment, Tretten. The U.S. launch is scheduled for early 2014.
The approval was based on encouraging data from a phase III study which demonstrated the safety and efficacy of Tretten. The study enrolling 41 patients showed that Tretten injections significantly decreased the number of treatment-requiring bleeding episodes when compared to a historic control group of individuals. The effectiveness of Tretten was studied in 77 patients with congenital Factor XIII A-subunit deficiency. Bleeding prevention was achieved in 90% of the patients when Tretten was given monthly.
Tretten is the first recombinant product in the routine prevention of bleeding in patients who have congenital Factor XIII A-subunit deficiency.
The drug is already approved in Canada, EU, Switzerland and Australia. Outside Canada and the U.S. the drug is marketed as NovoThirteen. Tretten also enjoys orphan-drug status in the U.S.
The news should come as a relief for Novo Nordisk as the FDA has issued a complete response letter in Aug 2013 for the same. Novo Nordisk resubmitted its application in Oct 2013.
With the approval of Tretten, Novo Nordisk has expanded its recombinant products portfolio. This will boost the hemophilia and rare bleeding disorders treatments.
Novo Nordisk has a strong presence in the Diabetes Care market with one of the broadest diabetes portfolios in the industry. Novo Nordisk carries a Zacks Rank #4 (Sell). Investors may consider other large cap pharma companies like Eli Lilly & Co. (LLY) and Novartis (NVS). Both carry a Zacks Rank #2 (Buy). Questcor Pharmaceuticals Inc. (QCOR) is also worth considering with a Zacks Rank #1 (Strong Buy).