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Baxalta Adynovate Gets Japanese Approval for Hemophilia A

Baxalta Incorporated BXLT announced that its hemophilia drug, Adynovate, has received a regulatory nod from the Japanese Ministry of Health, Labour and Welfare for the treatment of patients 12 years and older with hemophilia A. The drug was approved as a twice-weekly dosing schedule.

Adynovate is an extended circulating half-life recombinant factor VIII (rFVIII), based on Advate (Baxalta’s hemophilia A drug), a full-length FVIII molecule.

With this approval, Adynovate’s marketing authorization gets transferred from Baxter Limited to Baxalta Japan Limited.

According to a survey conducted by the World Federation of Hemophilia, the Japanese approval of Adynovate will extend its access to about 5,000 people in the country.

We remind investors that Adynovate is currently approved in the U.S. for the on-demand treatment and control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes in adolescent and adults (12 years and older) suffering from hemophilia A.

Moreover, a supplemental Biologics License Applications for Adynovate has been submitted to the FDA for the treatment of children under the age of 12 with hemophilia A, and for use in surgical settings. Adynovate (EU:Adynovi) is also under review in the EU for the treatment of pediatric, adolescent and adult patients with hemophilia A, and for use during surgery.

We note that Baxalta had developed Adynovate in collaboration with Nektar Therapeutics NKTR, using the latter’s PEGylation technology.

Currently approved drugs in the hematology space include Eloctate, Kovaltry, Obizur and Nuwiq among others.

Baxalta currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are AMAG Pharmaceuticals, Inc. AMAG and Emergent BioSolutions, Inc. EBS,  both sporting a Zacks Rank #1 (Strong Buy).

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