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Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval from FDA Advisory Committee
By: PR Newswire
Nov. 8, 2012 08:11 PM
WASHINGTON, Nov. 8, 2012 /PRNewswire/ -- 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 and risks of the products, including a lower rate of hypoglycemia and the potential 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 8-4 in favor of approving the products with a post-approval outcomes trial commitment.
"The positive vote from the Advisory Committee marks an important step toward making insulin degludec and insulin degludec/insulin aspart available to adult patients with diabetes in the U.S. We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial," said Alan Moses, global chief medical officer of Novo Nordisk.
The FDA has not informed Novo Nordisk of when it expects to complete its review of the NDAs.
On November 9 at 8:30 am CET (Central European Time), 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.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy, and hormone replacement therapy. For more information, visit novonordisk-us.com or follow our news in the US on Twitter: @NovoNordiskUS
SOURCE Novo Nordisk
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