Octapharma announces FDA approval of wilate

Octapharma has announced that the Food and Drug Administration (FDA) has approved wilate for the treatment of von Willebrand disease (VWD).

The therapy – which is a newly developed, high-purity, double virus inactivated coagulation factor VIII concentrate – is indicated for the curbing of spontaneous and trauma-induced bleeding episodes in patients with all types of VWD.

Four previous clinical trials have shown the tolerability, safety and hemostatic efficacy of wilate in the treatment of acute bleeding episodes and prophylaxis.

Craig Kessler, professor of medicine and pathology and director of the Division of Coagulation, commented: “The FDA approval of wilate makes this the first and only replacement therapy developed and manufactured specifically for VWD. [It] will provide a next-generation treatment option for patients.”

In other Octapharma news, the firm’s financial results for the second quarter of 2009 revealed record turnover for the company.

In the quarter ending June 2009, it saw a turnover of 536 million euros (496 million pounds), compared to 422 million euros in June 2008.