Wyeth’s Xyntha is reportedly the first recombinant factor VIII product that uses a synthetic purification process, and Abbotts Humira adds sixth indication to its label.
The FDA approved a treatment related to hemophilia A and a drug for juvenile idiopathic arthritis (JIA) patients. Wyeth Pharmaceuticals’ hemophilia A therapy has a novel manufacturing process, while Abbott Laboratories’ victory represents the sixth indication for blockbuster Humira.
Wyeth’s Xyntha, a recombinant factor VIII product, is sanctioned for the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A. It is manufactured using a completely albumin-free process and is reportedly the only recombinant factor VIII product to utilize an entirely synthetic purification process.
Since this recombinant Factor VIII is produced without additives from human or animal material, it minimizes any risk of infection from the therapy, points out Jesse Goodman, M.D., director of FDA’s Center for Biologics Evaluation and Research.
The purification process for all recombinant factor VIII products usually uses mAbs derived from mouse cell lines. In the manufacture of Xyntha, Wyeth explains that the mouse mAb is replaced with a synthetic peptide ligand discovered at the company.
Also reported today, FDA gave Abbott the go-ahead to market Humira as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years and older. Humira is the first biologic treatment to receive approval from the agency for this condition since 1999, according to the company.
JIA represents the sixth disease for which Humira has been sanctioned since 2002. Other indications include rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Humira achieved full-year worldwide sales in excess of $3 billion in 2007, Abbot reports. The company forecasts global sales for Humira of approximately $4 billion in 2008.