Swissmedic: Talidox® – A known substance with Innovation
In order to obtain certainty about the applicable regulatory requirements for the registration of TLD-1, InnoMedica has requested a Scientific Advice Meeting with Swissmedic.
We are pleased to announce that Swissmedic shares InnoMedica’s assessment of TLD-1 as a known substance with innovation.
Free doxorubicin has already been used in oncological practice since 1973 and the liposomal formulation (Caelyx/Doxil) is in clinical use for more than 20 years as well. This allows InnoMedica a faster approach to registration – for example, allowing for the execution of a simplified acute toxicity study. Talidox® will be tested in one species only, since InnoMedica can bridge existing data on the effect of free and liposomal doxorubicin with its own research results to show that Talidox® is a safe treatment option for humans.