FDA Accepts Ascelia Pharma's Orviglance NDA for Review, Sets PDUFA Date of July 3, 2026
The FDA has accepted Ascelia Pharma's NDA for Orviglance, a manganese-based oral MRI contrast agent for liver imaging in patients with severe kidney impairment, and set a PDUFA action date of July 3, 2026.
Ascelia Pharma AB (publ) (ticker: ACE) has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Orviglance® (manganese chloride tetrahydrate) for review. The FDA has set an action date of July 3, 2026, under the Prescription Drug User Fee Act (PDUFA).
The FDA confirmed through its "day 74 letter" the acceptance of the NDA filing for Orviglance and continuation of the review aiming for a decision by the PDUFA date. The NDA was originally submitted to the FDA on September 3, 2025, with Ascelia Pharma seeking marketing approval for Orviglance as a liver MRI contrast agent for patients with severe kidney impairment.
The NDA submission is based on the successful completion of the development program, which includes nine clinical studies with consistent positive efficacy and safety results. In the Phase 3 study, SPARKLE, Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, meeting the primary endpoint with statistical significance (<0.001).
Orviglance has been granted an Orphan Drug Designation by the FDA for use as a contrast agent for liver MRI in patients with severely impaired kidney function. These patients have the highest risk of developing the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF) after exposure to the gadolinium-based contrast agents normally used today. Regulatory bodies have issued warnings for the use of these agents in this vulnerable patient population. The unmet need for these patients represents a global annual addressable market potential of USD 800 million.
Orviglance is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. The company is actively seeking commercialization partners.
Ascelia Pharma is a biotech company focused on orphan oncology treatments, with global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). The company has two drug candidates – Orviglance and Oncoral – in development.