OXC-201 has secured Orphan Drug Designation from European Medicines Agency
Oxcia welcomes the European Medicines agency’s (EMA) decision to grant Orphan Drug Designation (ODD) for OXC-201 for idiopathic pulmonary fibrosis (IPF). An ODD from the European Medicines Agency (EMA) (https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview) is very valuable. It contains critical regulatory and financial incentives designed to encourage pharmaceutical companies to develop therapies for rare diseases with large unmet medical need. The primary advantages include 10 years of market exclusivity, scientific advice, help to design high-quality clinical
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