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Jaylon (NASDAQ:GLARLY) announced late Friday that the U.S. Food and Drug Administration (FDA) has approved its lead drug, imetelstat, as a late-stage option for a type of blood cancer called myelodysplastic syndrome (MDS).
Therefore, the telomerase inhibitor imetelstat will be used in Rytelo in the United States is indicated for adults with low-to-moderate risk MDS who are anemic and require blood transfusions.
This treatment will be available to people who are unresponsive or ineligible to receive a class of drugs called erythropoiesis-stimulating agents.
With the approval, Geron (GERN) will compete with Bristol-Myers Squibb (BMY) and Merck & Co. (MRK), which market Reblozyl, another MDS therapy approved for low-risk patients.
The approval came after an FDA advisory committee voted 12-2 in March in favor of imetelstat. The company plans to hold a conference call at 8 a.m. ET on Friday to discuss the regulatory victory.
