Pharma/Biotech Update: Baxter Looks to Gain FDA Approval for vWD Drug

Big pharmaceutical news coming out of Baxter International today pertaining to the most common hereditary coagulation disorder, von Willebrand Disease. The company submitted a biologics license application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for the approval of BAX111.  BAX 111 will be the first highly-purified recombinant von Willebrand Factor (rVWF) in clinical development as a treatment for patients with von Willebrand disease, the most common type of inherited bleeding disorder. Orphan-drug designation has already been granted for BAX 111 by the European Commission and the U.S. Food and Drug Administration.

”If approved, BAX111 will be the first recombinant replacement treatment for von Willebrand disease, offering an important new option that may provide greater flexibility in treating patients with this challenging disease,” said John Orloff, vice president and global head of research and development at Baxter BioScience, in an article obtained from MarketWatch. ”Filing for U.S. approval for this treatment helps us further advance our pursuit of new treatment options and improved quality of care for people with a range of bleeding disorders around the world.”

WeBleed will post updates on the outcome of the FDA application of BAX 111 as it becomes available.

Photo Credit – Baxter International 

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