HPBCD-formulated Cladribin – a new CD-enabled drug formulation on the market

News 25 April, 2018
HPBCD-enabled Cladribine formulation has been authorized in Europe on 22.08.2017 under the trade name Mavenclad against multiple sclerosis.
Cladribine formulations for improved oral and transmucosal delivery were submitted as patent application to the US in 2003 and as PCT in 2004 by Nicholas Bodor (Ares Trading SA). Based on the patents US8623408 and EP2272503 the new formulation was approved by EMA. The marketing authorization holder is Merck Serono Europe Ltd. The mechanism by which Mavenclad exerts its therapeutic effect in multiple sclerosis is not fully elucidated, but its predominant effect on B and T lymphocytes is thought to interrupt the cascade of immune events central to multiple sclerosis. The application of HPBCD aims at enhancing solubility and oral bioavailability of cladribine.