The Food and Drug Administration (FDA) has approved Xenoview (xenon Xe 129 hyperpolarized), a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients 12 years of age and older.

The approval was based on data from 2 prospective, multicenter, randomized, open-label, crossover trials (ClinicalTrials.gov Identifier: NCT03417687 [Study 1], NCT03418090 [Study 2]) that compared Xenoview MRI to xenon Xe 133 scintigraphy in adults with pulmonary disorders. Study 1 included patients being evaluated for possible lung resection surgery. Study 2 included patients being evaluated for possible lung transplant surgery.

In the primary analysis of 31 patients in Study 1, results showed that the mean within-patient difference in the predicted postoperative percentage of remaining lung ventilation between Xenoview and xenon Xe 133 imaging was within a prespecified equivalence interval with an observed estimate of 1.4% (95% CI, -0.8%, 3.6%).

In the primary analysis of 49 patients who completed both scans in Study 2, the mean within-patient difference in the percentage of overall lung ventilation contributed by the right lung between Xenoview and xenon Xe 133 imaging was within a prespecified equivalence interval with an observed estimate of 1.6% (95% CI, -3.7%, 0.5%).

The most common adverse reactions reported in clinical trials included oropharyngeal pain, headache, and dizziness.

Xenoview is a clear, colorless, odorless gas contained in a 1000mL Xenoview Dose Delivery Bag. The bag contains at least 75mL Dose Equivalent of hyperpolarized xenon Xe 129 in a volume of 250mL to 750mL total xenon. The product is administered by oral inhalation as a single 10-15 second breath hold MRI procedure.

Additionally, the FDA has approved Xenoview VDP, an image analysis platform, and Xenoview 3.0T Chest Coil, to be used in conjunction with compatible MRI scanners and Xenoview for evaluation of lung ventilation.

References

  1. FDA approves Polarean’s Xenoview (xenon Xe 129 hyperpolarized) for use with MRI for the evaluation of lung ventilation. News release. Polarean Imaging plc. December 28, 2022. Accessed December 29, 2022. https://www.globenewswire.com/news-release/2022/12/28/2580194/0/en/FDA-Approves-Polarean-s-XENOVIEW-xenon-Xe-129-hyperpolarized-for-use-with-MRI-for-the-Evaluation-of-Lung-Ventilation.html.
  2. Xenoview. Package insert. Polarean Imaging plc; 2022. Accessed December 29, 2022. https://polareanstage.wpengine.com/wp-content/uploads/2022/12/2022-12-21-Xenoview-Prescribing-Information-final.pdf.