Novo Nordisk Gets FDA Nod for NovoSeven RT - Analyst Blog

Novo Nordisk's NVO NovoSeven RT (coagulation factor VIIa [recombinant]) received FDA approval for perioperative management and the treatment of bleeding episodes in patients suffering from Glanzmann's thrombasthenia (a rare genetic bleeding disorder) with refractoriness to platelet transfusions (with or without antibodies to platelets). NovoSeven RT is the first recombinant treatment to gain FDA approval for this indication.

According to the press release issued by Novo Nordisk, one out of a million is diagnosed with this disease globally, and suffers from a lifelong susceptibility towards bleeding episodes, which might be potentially life threatening.

NovoSeven RT is already approved for Glanzmann's thrombasthenia in the EU.

We note that NovoSeven is also approved for the treatment and prevention of bleeding in surgeries and procedures in adults and children suffering from hemophilia (A or B) with inhibitors, acquired hemophilia or congenital factor VII (FVII) deficiency. In Feb 2013, Novo Nordisk launched NovoSeven with a pre-filled syringe under the trade name ‘NovoSeven RT with MixPro' in the U.S. and ‘NovoSeven with pre-filled syringe' in the EU.

In 2013, NovoSeven generated total sales of DKK 9.3 million, up 3.6% y/y. We are pleased to see NovoSeven RT's approval in the U.S. for Glanzmann's thrombasthenia. This will expand the eligible customer base for the drug and strengthen its position in the market for coagulation factors.

Novo Nordisk carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Abbott Laboratories ABT, AbbVie Inc. ABBV and Allergan Inc. AGN. All these stocks carry a Zacks Rank #2 (Buy).

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