Ipsen Announces FDA's Priority Review of Elafibranor for PBC Treatment, with EMA Also Validating MAA

Ipsen has recently made a significant stride forward with its novel therapeutic candidate, elafibranor, aimed at treating primary biliary cholangitis (PBC), a rare liver disease. The United States Food and Drug Administration (FDA) has elevated the review process of the New Drug Application (NDA) for elafibranor to a priority status. This coveted classification underscores the potential importance of elafibranor in fulfilling an unmet medical need within the domain of cholestatic liver diseases. A Prescription Drug User Fee Act (PDUFA) date, which marks the deadline for the FDA's decision on the approval, has been scheduled for June 10, 2024.

Global Regulatory Milestones for Elafibranor

Complementing the advancements in the United States, Ipsen has also reached a regulatory milestone in Europe. The European Medicines Agency (EMA) has validated the company's Marketing Authorization Application (MAA) for elafibranor. Validation by the EMA is the first step in the process for the approval of new medicines in the European Union, indicating that the review process for elafibranor as a potential treatment of PBC can commence. The parallel progress both in the US and EU regulatory systems highlights the global commitment and urgent need for new interventions against PBC, driving Ipsen's candidate closer to potential market approval and patient access.

Genfit SA GNFT, a France-based biopharmaceutical company leading the development of drug candidates and diagnostic solutions in metabolic and liver-related diseases, is the entity behind the discovery of elafibranor. Its commitment to addressing the challenging landscape of liver diseases has propelled the investigation of elafibranor, exemplifying GNFT's dedication to improving patient outcomes in complex health conditions. As a priority review designation in the US and the MAA validation in the EU signify important steps towards potential commercialization, these events could influence GNFT's market performance and are of notable interest to investors monitoring the biopharmaceutical sector.

FDA, EMA, PBC