FDA Schedules Advisory Committee Meeting for Insulin Degludec and Insulin Degludec/Insulin Aspart

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has informed the company that an FDA Advisory Committee meeting is tentatively scheduled to be held on 8 November 2012 to discuss the New Drug Applications (NDA) for the ultra-long-acting insulin degludec and insulin degludec/insulin aspart.

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.

Novo Nordisk submitted the NDAs to the FDA on 29 September 2011, and on 8 June this year, the FDA informed Novo Nordisk that the updated action date is 29 October 2012. In its communication about the advisory committee meeting the agency has not informed Novo Nordisk of a new action date.


About insulin degludec and insulin degludec/insulin aspart
Insulin degludec is a once-daily, ultra-long-acting basal insulin analogue 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, BEGIN™, 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 ultra-long-acting 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 ultra-long-acting 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 have been 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.


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 33,000 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.


Media:
Investors:
Mike Rulis
Kasper Roseeuw Poulsen
Tel: (+45) 3079 3573
Tel: (+45) 4442 4303
mike@novonordisk.com
krop@novonordisk.com
Frank Daniel Mersebach
Tel: (+45) 4442 0604
fdni@novonordisk.com
Lars Borup Jacobsen
Tel: (+45) 3075 3479
lbpj@novonordisk.com
In North America:
Ken Inchausti
Jannick Lindegaard
Tel: (+1) 609 514 8316
Tel: (+1) 609 786 4575
kiau@novonordisk.com
jlis@novonordisk.com

Posted: July 2012


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