ECTRIMS 2016: What Future For Merck KGaA’s Cladribine?

16 Sep 2016

• By Ines Guerra

With the EMA’s review of the latest MAA for cladribine ongoing, Merck KGaA is using ECTRIMS 2016 as the stage for numerous new presentations on the drug’s efficacy and safety. Data on this additional induction therapy are positive but regulators and the market could prove difficult to persuade.

SC1609_Hurdles_1200x675 — • Source: Shutterstock; Jne Valokuvaus

The 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2016) in London is bearing witness to the reappearance of Merck KGAA’s oral induction therapy cladribine, with an ample number of presentations covering the drug’s safety and efficacy. And while new safety data in particular might help the drug finally gain approval, the changes in the MS market in recent years mean higher commercial hurdles.

Most of the ECTRIMS presentations include analyses of data from already-known trials, namely the Phase III CLARITY, CLARITY Extension, and...