The European IMI2-funded LITMUS consortium has reached a major milestone in the biomarker qualification process by having our letter of intent (LOI) accepted by the U.S. Food and Drug Administration (FDA). With this LOI, LITMUS aims to qualify non-invasive biomarkers to enable simpler diagnosis and better treatment for patients with non-alcoholic steatohepatitis (NASH). The FDA supports and encourages the study of non-invasive biomarkers for NASH, where better tools to diagnose and treat patients are needed. The acceptance allows LITMUS to submit a qualification plan, providing a more comprehensive description of the steps the requestor will take to provide the necessary supportive data for biomarker qualification. At the same time LITMUS has also finalized two scientific advice interactions with the European Medicines Agency (EMA).
Members of the WP7 Regulatory team involved in creating the LOI are as follows:
- Elisabeth Erhardtsen (Nordic Bioscience)
- Richard Torstenson (Abbvie)
- Daniel Guldager Kring Rasmussen (Nordic Bioscience)
- Morten Karsdal (Nordic Bioscience)
- Guido Hanauer (Takeda)
- Camilla Bertelsen (Novo Nordisk)
- Julia Brosnan (Pfizer)
- Vlad Ratziu (Hôpital Pitié-Salpêtrière, Paris)
- Patrick Bossuyt (Amsterdam University Medical Centre)
- Quentin M. Anstee (Newcastle University)