FDA Approves CSL Behring's Rhophylac for Platelet Disorder

CSL Behring announced that the FDA has approved an additional indication for Rhophylac, 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-positive, non-splenectomized adult patients with chronic ITP.

Rhophylac was previously approved for preventing hemolytic disease of the newborn, for suppressing Rh isoimmunization in non-sensitized Rh-negative women and for Rh prophylaxis in case of obstetric or pregnancy complications.

In an open-label, single-arm, multicenter trial, Rhophylac was shown to be safe and effective in the treatment for ITP. In the trial, response rates for an increase in platelet counts to greater than 50 x 10(9)/L ranged from 26 to 100 percent. The overall regression of hemorrhage achieved was 88 percent in 50 patients with bleeding at baseline.

Rhophylac, derived from human plasma, is manufactured using CSL Behring's unique ChromaPlus process, yielding a safe, highly pure and stable product. Coupled with careful donor selection and screening, the ChromaPlus process significantly reduces the risk of viral transmission. In clinical studies, there was no evidence of viral transmission with Rhophylac.