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EU Nod for Novo Nordisk Drugs

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Novo Nordisk (NVO - Free Report) recently announced that it has received approval in the EU (covering all 27 states) for its diabetes treatments, Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart).

The EU approval for Tresiba and Ryzodeg was expected as both drugs had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the EU in Oct 2012 .

Under ‘treat to target’ studies, Tresiba was compared to insulin glargine and Ryzodeg was compared to NovoMix, and both showed a significantly lower risk of overall and nocturnal hypoglycemia, while successfully achieving equivalent reductions in HbA1c.

Ryzodeg is a soluble formulation of Tresiba (insulin degludec) and NovoRapid (insulin aspart – known as NovoLog in the US).  Tresiba and Ryzodeg will be available in Novo Nordisk’s latest prefilled insulin pen named FlexTouch in Europe.

Novo Nordisk is planning to launch Tresiba first and Ryzodeg a year later. Tresiba will initially be launched in the UK and Denmark in the first half of 2013 and in other European markets throughout 2013 and 2014.

We note that Ryzodeg and Tresiba are currently under US Food and Drug Administration (FDA) review for the treatment of diabetes in adults. The candidates received a positive vote for approval from an FDA Advisory Committee in the US in Nov 2012. We expect approval shortly.

Additionally, Novo Nordisk is seeking regulatory approval for Tresiba and Ryzodeg in Canada, Switzerland and several other countries.  Ryzodeg and Tresiba are also approved in Japan.

Our Take

We are pleased with the company’s efforts to strengthen its presence in the diabetes market. Novo Nordisk carries a Zacks Rank #2 (Buy).

Other pharmaceutical companies performing well are Salix Pharmaceuticals and Valeant Pharmaceuticals (VRX - Free Report) , both of which carry a Zacks Rank #1 (Strong Buy). Additionally, BioCryst Pharmaceuticals (BCRX - Free Report) is also performing well and carries a Zacks Rank #2.

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