FDA clears CSL Behring's Rhophylac for ITP

The US Food and Drug Administration has granted marketing approval for an additional indication for CSL Behring' Rhophylac Rh(0)(D) (immunoglobulin intravenous [human]), an anti-D Rh immunoglobulin. The additional indication is for the treatment of immune thrombocytopenic purpura (ITP). Administered intravenously, Rhophylac is indicated to raise platelet counts in Rh(0)(D)-positive, non-splenectomized adult patients with chronic ITP. Having established efficacy and safety in over 10 years of use for other indications, Rhophylac offers high value pricing to help health care practitioners manage costs, the company claims

Paul Perreault, executive vice president of worldwide commercial operations, CSL Behring, commented: "in an environment of rising health care costs, Rhophylac provides the right balance of value and cost, while continuing the company's long tradition of providing patients with safe and effective therapies."

In an open-label, single-arm, multi-center trial, Rhophylac proved safe and effective in the treatment for ITP. In this, 98 Rh(0)(D)-positive adult chronic ITP patients with platelet counts of