Calliditas Therapeutics announced that the European Medicines Agency, or EMA, Committee for Orphan Medicinal Products, or COMP, has issued an opinion on the company’s application for orphan drug designation in the European Union, or EU, for setanaxib in Alport syndrome. The COMP opinion will now go to the European Commission, which is responsible for adopting the decision in relation to the application for orphan designation and adding it to the Community register of orphan medicinal products for human use.
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