<a href="https://www.fiercebiotech.com/biotech/mirum-maps-fda-path-after-anti-itch-candidate-scores-ph-2-win" hreflang="en">Mirum maps FDA path after anti-itch candidate scores ph. 2 win</a>
Mirum Pharmaceuticals is preparing to submit a new FDA application for its anti-itch drug volixibat after it demonstrated significant effectiveness in reducing itching in patients with primary sclerosing cholangitis during a phase 2 trial. The company plans to discuss the application with the FDA this summer, highlighting the potential of volixibat as a meaningful treatment option for a condition with currently no approved therapies.
Mirum Pharmaceuticals' successful phase 2 trial of volixibat, an IBAT inhibitor, for treating pruritus in primary sclerosing cholangitis (PSC) patients, positions the company for a potentially significant FDA approval submission later this year. As there are currently no FDA-approved treatments for PSC, this development could represent a substantial market opportunity and advance in managing a challenging disease, making it a focal point for investors and stakeholders in the biotech sector watching for innovative solutions in rare liver diseases.