Bagsværd, Denmark, 10 February 2013 – Novo Nordisk today announced that on 8
February 2013 it received a Complete Response Letter from the US Food and Drug
Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec)
and Ryzodeg® (insulin degludec/insulin aspart). A Complete Response Letter is issued by
the FDA, when the agency determines that an application cannot be approved in its
In the letter, the FDA requests additional cardiovascular data from a dedicated
cardiovascular outcomes trial before the review of the New Drug Applications can be
completed. Novo Nordisk is evaluating the content of the Complete Response Letter and
will work closely with the FDA to provide the requested data. Novo Nordisk does not
expect to be able to provide the requested data during 2013.
In the letter, the FDA also states that approvals for Tresiba® and Ryzodeg® cannot be
granted until the violations cited in the previously announced Warning Letter, dated 12
December 2012, have been resolved.
“We are convinced that Tresiba® and Ryzodeg® offer significant benefits for people who
require insulin”, said Lars Rebien Sørensen, chief executive officer of Novo Nordisk. “We
are surprised and disappointed to receive this letter, but we acknowledge this decision
by the FDA and will work with the agency to determine the best path forward to
completing the review.”
The New Drug Applications for Tresiba® and Ryzodeg® were submitted by Novo Nordisk
to the FDA in September 2011. In November 2012, at an FDA Endocrinologic and
Metabolic Drugs Advisory Committee meeting, a panel of independent scientific experts
unanimously recommended that a cardiovascular outcomes trial should be conducted and
voted eight to four in favour of approving the products with a post-approval
cardiovascular outcomes trial commitment.
Tresiba® and Ryzodeg® are approved in Japan, the EU and Mexico and under regulatory
review in a number of countries throughout the world.
The Complete Response Letter is not expected to significantly impact Novo Nordisk's
expectations for the company's financial results for 2013, which were provided on 31
January 2013 in connection with the release of the financial results for 2012.
On 11 February at 8.00 am CET, corresponding to 2.00 am EST, a conference call for
investors will be held. Investors will be able to listen in via a link on the investor section
Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care.
The company also has leading positions within haemophilia care, growth hormone therapy and hormone
replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 35,000
employees in 75 countries, and markets its products in more than 180 countries. Novo Nordisk’s B
shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock
Exchange (NVO). For more information, visit novonordisk.com.
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