Positive interactions with EMA provide route to conditional marketing authorization of lead candidate Nefecon
Calliditas Therapeutics AB (publ) (“Calliditas”) today announced that the European Medicines Agency (EMA) has provided positive guidance related to a conditional marketing authorization (CMA) of the company’s lead compound Nefecon, currently in Phase 3 clinical trials in IgA nephropathy (IgAN).
In a written response received from EMA, the agency agreed that it could support CMA assessment, subject as usual to the strength of the full data set presented at the time of filing, which will also include an analysis by Calliditas related to the likelihood of achieving success in Part B of the ongoing Phase 3 study NefIgArd.
This positive outcome reflects the availability of strong Phase 2b data, a critical statistical analysis approach and a clear and compelling Phase 3 study design. The NefIgArd study was initiated in November 2018 and is currently running, with expected readout of topline data in second half of 2020.
