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Baxalta's Hemophilia Drugs Adynovate and Obizur Approved

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Baxalta IncorporatedBXLT gained approval for two hemophilia drugs - Adynovate and Obizur - in the U.S. and EU, respectively.

Adynovate Gains FDA Approval

Adynovate gained FDA approval for the treatment of patients suffering from hemophilia A. Adynovate is an extended circulating half-life recombinant factor VIII (rFVIII), based on Advate (Baxalta's hemophilia A drug), a full-length FVIII molecule.

Adynovate is expected to provide patients with a simple, twice-weekly dosing schedule compared to conventional 3-4 doses weekly. The drug is expected to hit the U.S. markets in the coming weeks.

We note that Adynovate is currently under regulatory review in Japan. Meanwhile, Baxalta is working on expanding Adynovate's label further. Currently, the company is conducting studies in previously treated patients (PTPs) with severe hemophilia A undergoing surgery and pediatric PTPs under the age of 12 years with severe hemophilia A. Baxalta also plans to commence a study in previously untreated patients with severe hemophilia A. The company expects to file for EU approval, once the pediatric study is completed.

We note that Baxalta developed Adynovate using Nektar Therapeutics' NKTR PEGylation technology.

Obizur Receives EU Approval

Baxalta also announced that Obizur gained approval in the EU for the treatment of bleeding episodes in adults with acquired hemophilia A caused by antibodies to FVIII. Approval makes Obizur the first recombinant porcine sequence FVIII treatment for acquired hemophilia A in the EU.

We note that Obizur is already approved in the U.S. for the treatment of acquired hemophilia A.

We are encouraged by Baxalta gaining approval for two drugs at once. The company expects to launch 20 products by 2020.

Baxalta is a Zacks Rank #1 (Strong Buy) stock. Other favorably ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN and Actelion Ltd. ALIOF .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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