Positive interactions with EMA provide route to conditional marketing authorization of lead candidate Nefecon

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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

Source: Positive interactions with EMA provide route to conditional marketing authorization of lead candidate Nefecon

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