CRL issued for Ascelia's Orviglance NDA in liver-MRI
- Sponsor
- Ascelia Pharma $ACE.ST
- Drug
- Orviglance · manganese chloride tetrahydrate
- Indication
- contrast-enhanced liver MRI in patients with severe kidney impairment
FDA issued a Complete Response Letter for Ascelia Pharma's Orviglance (manganese chloride tetrahydrate) NDA for contrast-enhanced liver MRI in patients with severe kidney impairment, citing deficiencies in clinical data (image reading process) and product documentation.
What this means
Orviglance is Ascelia Pharma's oral manganese-based liver MRI contrast agent, developed for patients with severe kidney impairment who cannot safely receive gadolinium-based contrast agents. FDA declined to approve the NDA, citing deficiencies in two areas: additional clinical data (which Ascelia views as related to the image reading process in the pivotal Phase 3 SPARKLE study) and product documentation. Unlike the other three CRLs this week (Elevar rivoceranib-camrelizumab, Camurus CAM2029, Sobi NASP — all quality-caused via third-party contract manufacturers), Ascelia's Orviglance CRL is NOT primarily a manufacturing / cGMP failure. The clinical component means the resubmission scope may extend beyond documentation to additional reader-adjudication or imaging-workflow data.