The FDA program facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions
Calliditas Therapeutics has announced the FDA has granted fast track designation (FTD) for its NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe.
The FDA program facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need. The FDA created this process to expedite the delivery of important drugs to patients, and programs with the designation can potentially take advantage of early and frequent communication with the FDA, as well as rolling submission of the marketing application.
“We are delighted to receive Fast Track designation and look forward to working closely with the FDA towards our aim of establishing setanaxib as the potential first NOX inhibitor for PBC patients,” said CEO Renée Aguiar-Lucander.
In a Phase II clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favourable tolerability profile, as well as a statistically significant impact on fatigue. The company is planning to initiate a pivotal Phase II/III study in PBC, starting in H2 2021.