SangStat Ciclosporin Takes On Sandimmun

SangStat has reported data from a clinical trial which indicates thatkidney transplant patients currently on treatment with Novartis' branded version, Sandimmun (ciclosporin), do better when switched to its generic version of ciclosporin.

Although a majority of transplant patients have been switched to Novartis' improved ciclosporin formulation Neoral, a sizeable minority (estimated at 30%) remain on Sandimmun in the USA. SangStat has already shown that its Sang-35 product is bioequivalent to Neoral (although these data have not yet been reviewed by the US Food and Drug Administration), but wanted to show that it was safe for those on Sandimmun to be switched to the generic.

Conversion from Sandimmun to Sang-35 resulted in ciclosporin blood levels increasing by an average of 12%. Patients were followed up for at least four months and conversion was safely performed without acute rejection or any unexplained side effects, according to SangStat. In 10% of patients there was no need for dose adjustment, while a single dose adjustment was needed in 45%, 31% of patients needed two, and 14% needed three. In some patients, dose reduction may be possible.