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FDA Approves Adynovate for Hemophilia A

For on-demand treatment and twice-weekly prophylaxis

Publish date:: November 18, 2015

Baxalta announced that FDA has approved Adynovate, an extended circulating half-life recombinant Factor VIII treatment for hemophilia A. Adynovate is built on the full-length Advate molecule, a leading treatment for hemophilia A.

Indication: Adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for:

• On-demand treatment and control of bleeding episodes.

• Routine prophylaxis to reduce the frequency of bleeding episodes.

Adverse Reactions: Common adverse reactions reported in clinical studies were headache and nausea.

Citation: Baxalta to advance care for hemophilia A patients with FDA approval of Adynovate, a simple, twice-weekly treatment to reduce bleeds. [news release]. Bannockburn, IL: Baxalta; November 13, 2015. http://newsroom.baxalta.com/press-releases/press-release-details/2015/Baxalta-to-Advance-Care-for-Hemophilia-A-Patients-with-FDA-Approval-of-ADYNOVATE-a-Simple-Twice-weekly-Treatment-to-Reduce-Bleeds/default.aspx. Accessed November 13, 2015.

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