NDA Submitted to FDA for Imetelstat

A New Drug Application (NDA) for the telomerase inhibitor imetelstat has been submitted to the US Food and Drug Administration (FDA). Imetelstat is used in the treatment of transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have failed to respond, have lost response to, or are ineligible for erythropoiesis-stimulating agents.

The NDA submission is based on results from the IMerge phase III trial, in which the primary endpoint of eight-week transfusion independence was significantly higher with imetelstat versus placebo in patients with MDS (P<.001). The mean hemoglobin levels in patients receiving imetelstat increased significantly (P<.001) over time compared to patients receiving placebo, according to Geron, the manufacturer of the drug.

Geron is expected to submit a Marketing Authorization Application in the European Union in the second half of 2023.

Source: Businesswire, June 2023