FDA
accepts Novo Nordisk's resubmitted application for
insulin drug
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[April 08, 2015]
(Reuters) - Denmark's Novo Nordisk
A/S said the U.S. Food and Drug Administration accepted a resubmitted
application for its key insulin drug, Tresiba, based on interim analysis
data from a clinical trial.
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Tresiba, already available outside the United States, was rebuffed
by the FDA two years ago on concerns that the drug could be linked
to higher rates of heart attacks or strokes.
The agency had asked Novo to conduct a dedicated trial to test for
such risks, and the company said on Tuesday that it expects to
complete the study in the second half of 2016.
When Novo said in late March that it was looking to resubmit the
marketing application for Tresiba and a related drug, industry
analysts had estimated Tresiba could get approved as early as
October this year, based on the interim data.
Had Novo waited to weave in the results from the full trial in its
application, Tresiba would likely not have hit the U.S. market in
2016, putting the world's top insulin maker behind its main rival
Sanofi.
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A U.S. launch within the next year may help Tresiba see off rival
products, most notably Sanofi's Toujeo, designed to succeed the
French drugmaker's blockbuster drug, Lantus.
Tresiba, a long-acting form of insulin known chemically as degludec,
is currently forecast to generate annual sales of $2.2 billion by
2020, according to Thomson Reuters Cortellis.
Tresiba also gives Novo an important foundation for future
combination regimens in the United States, which accounts for
slightly more than half of a $23 billion global diabetes market,
Morningstar's Karen Andersen said in note in March.
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Novo Chairman Göran Ando had told Reuters in March last year that
getting Tresiba approved by the FDA was one of the most important
short-term goals for the company.
The company's U.S.-listed shares were little changed in extended
trade on Tuesday.
(Reporting by Natalie Grover in Bengaluru; Editing by Don Sebastian
and Savio D'Souza)
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