MR contrast developer Epix Pharmaceuticals has received an approvable letter from the U.S. Food and Drug Administration for its MS-325 MR blood pool contrast agent.
The FDA has requested additional clinical studies to demonstrate efficacy, however, prior to approval, according to the Cambridge, MA-based vendor. Epix said that the agency's principal questions relate to the noncontrast MRA comparator scans used in the phase III trials, and to the statistical treatment of uninterpretable images.
The letter identified no safety or manufacturing deficiencies. Epix said it is continuing an active dialogue with the FDA to determine the next steps needed to gain approval for MS-325.
By AuntMinnie.com staff writers
January 14, 2005
Related Reading
Epix shows Q3 downturn, October 27, 2004
Epix Medical changes name, September 8, 2004
Epix begins testing blood clot imaging agent, August 6, 2004
Epix names Uprichard president and COO, July 16, 2004
Epix testing MS-325 for cardiac imaging, July 12, 2004
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![Representative example of a 16-year-old male patient with underlying X-linked adrenoleukodystrophy. (A, B) Paired anteroposterior (AP) chest radiograph and dual-energy x-ray absorptiometry (DXA) report shows lumbar spine (L1 through L4) areal bone mineral density (BMD). The DXA report was reformatted for anonymization and improved readability. The patient had low BMD (Z score ≤ −2.0). (C) Model (chest radiography [CXR]–BMD) output shows the predicted raw BMD and Z score in comparison with the DXA reference standard, together with interpretability analyses using Shapley additive explanations (SHAP) and gradient-weighted class activation maps. The patient was classified as having low BMD, consistent with the reference standard. AM = age-matched, DEXA = dual-energy x-ray absorptiometry, RM2 = room 2, SNUH = Seoul National University Hospital, YA = young adult.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/ai-children-bone-density.0snnf2EJjr.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
