) is seeking regulatory approval for its hemophilia A candidate
turoctocog alfa (NN7008). Novo Nordisk submitted its application
for the candidate both in the US and the EU. The company is
looking to get turoctocog alfa, a third-generation recombinant
coagulation factor VIII, approved for the prevention and
treatment of bleeding in patients suffering from hemophilia A.
Novo Nordisk's marketing authorization application for the
candidate was based on positive results from its phase III
trials, guardian 1 and guardian 3. The guardian trials, which
ended last year, enrolled more than 200 people having hemophilia
A and was the largest clinical pre-registration trial program
conducted for the disease.
Novo Nordisk is planning to submit regulatory applications in
other countries as well in the coming months.
We remind investors that the company suffered a pipeline setback
last month. Novo Nordisk decided to terminate the development of
its phase III hemophilia candidate, vatreptacog alfa. Vatreptacog
alfa, a fast-acting recombinant factor VIIa analogue, was being
developed for hemophilia patients with inhibitors.
Novo Nordisk's decision followed the analysis of data from a
double-blinded, randomized, controlled phase IIIa (adept 2)
study, where patients received either vatreptacog alfa or
NovoSeven, an approved product of Novo Nordisk.
The hemophilia A market currently has players like
Baxter International Inc.
We note that Novo Nordisk received positive news last month when
Tresiba (insulin degludec) gained approval in Japan. The Japanese
Ministry of Health, Labour and Welfare (MHLW) approved Tresiba, a
next-generation, once-daily basal insulin, for the treatment of
type I and type II diabetes. The Japanese approval marks the
first approval for Tresiba, which is under regulatory review in
several countries including the US, the EU, Switzerland, Canada,
South Africa, India, Australia, Brazil, Mexico and Russia.
We have an Outperform recommendation on Novo Nordisk. The stock
carries a Zacks #1 Rank (Strong Buy rating) in the short
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