Bagsværd, Denmark, 9 November 2012 Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Applications (NDA) for insulin degludec and insulin degludec/insulin aspart.
At the meeting, the Advisory Committee was asked to discuss the data contained in the NDAs and subsequent submissions regarding the benefits associated with a lower risk of hypoglycaemia and the cardiovascular risk profiles of the two products.
The FDA asked the panel members to vote on whether a cardiovascular outcomes trial should be conducted and whether sufficient safety and efficacy data had been provided to support marketing of insulin degludec and insulin degludec/insulin aspart.
The committee 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 outcomes trial commitment.
"The positive vote from the Advisory Committee marks an important step towards making insulin degludec and insulin degludec/insulin aspart available to patients with diabetes in the US. We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The FDA has not informed Novo Nordisk of when it expects to complete its review of the NDAs.
On 9 November at 8.30 am CET, corresponding to 2.30 am EST, a conference call for investors will be held. Investors will be able to listen in via a link on the investor section of novonordisk.com.
Novo Nordisk A/S
Novo Allé 2880 Bagsværd Denmark
Telephone: +45 4444 8888 Telefax: +45 4444 2314
Internet: www.novonordisk.com CVR no: 24 25 67 90
Company announcement No 72 / 2012
About advisory committee meetings
FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing new drug applications. According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer new drugs to an advisory committee meeting, or alternatively justify why an advisory committee meeting was not requested.
About insulin degludec and insulin
Insulin degludec is a once-daily new-generation basal insulin analogue, with an ultra- long duration of action, discovered and developed by Novo Nordisk. Insulin degludec has a distinct slow absorption which provides a flat and stable action profile. Insulin degludec has been studied in a large-scale clinical trial programme, BEGINTM, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust insulin degludec dosing time to suit patient needs.
Insulin degludec/insulin aspart contains the new-generation basal insulin degludec in a formulation with a bolus boost of insulin aspart. Insulin degludec/insulin aspart is the first and only soluble insulin combination of insulin degludec and the most prescribed rapid-acting insulin, NovoRapid® (NovoLog® in the US), providing both fasting and post- prandial glucose control.
Insulin degludec and insulin degludec/insulin aspart were submitted to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in September 2011 for regulatory review. In addition, applications have been submitted for regulatory approval in Japan, Canada, Switzerland and a range of other countries. Insulin degludec was approved in Japan in September 2012, and in October 2012 insulin degludec and insulin degludec/insulin aspart received positive CHMP opinions in Europe.
Novo Nordisk is a global healthcare company with 89 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 33,900 employees in 75 countries, and markets its products in more than 190 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.