EMA recommends Novo Nordisk’s insulin for EU approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that Novo Nordisk’s long-acting insulin, Tresiba (degludec), is approved for use in Europe. The European Commission usually follows the panel’s recommendation.
Diabetes treatments are a major target for drug company investment, due to the rise of type 2 diabetes, linked to obesity, worldwide. Novo Nordisk’s aim is to lead the long-acting insulin market, which Sanofi currently dominates, with Tresiba. It is expected to launch the drug in several European markets in early 2013, subject to final approval.
This European endorsement follows regulatory delays for the diabetes treatment in the United States, where Novo Nordisk expects the bulk of future sales to be generated. The FDA will be convening an advisory committee meeting to assess Tresiba for US use on November 8th 2012.
Novo Nordisk Wins EU Panel’s Recommendation for Tresiba (Bloomberg News)
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