Novo Nordisk gets EU recommendation for Tresiba use in kids

Novo Nordisk ($NVO) has a while yet to wait for another shot at FDA approval for Tresiba, a drug on which it has pinned its future, but it continues win support for it in Europe. The company said today that the European Committee for Medicinal Products for Human Use (CHMP) has backed approval of the drug for treatment of diabetes in children and adolescents, Reuters reports. Approval usually comes within a few months after a recommendation from CHMP. Novo's highly anticipated Tresiba was expected to be a head-on competitor with industry giant Lantus, but in early 2013, the FDA denied approval, asking for more data on its safety. The EU, however, gave it approval. Novo has said it expects to report critical clinical trial data on the long-acting insulin treatment in mid-2015, putting it in line for an approval in the U.S. in 2016. Story | More

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