) 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
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
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.
). Both carry a Zacks Rank #2 (Buy).
Questcor Pharmaceuticals Inc.
) is also worth considering with a Zacks Rank #1 (Strong
LILLY ELI & CO (LLY): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
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