Dasynoc granted Orphan Drug Designation in the US for the treatment of chronic myeloid leukemia
Regulatory press release 2022-06-17
Xspray Pharma (Nasdaq Stockholm: Xspray) today announced that the US Food and Drug Administration (FDA) has granted Dasynoc Orphan Drug Designation (ODD) in the US for the treatment of chronic myeloid leukemia (CML).
The FDA decision to grant the designation is based on the plausible hypothesis that Dasynoc may be clinically superior to the same drug(s) already approved for the same indication because Xspray Pharmas product candidate may provide a major contribution to patient care due to the gastric pH-resistant qualities of its formulation and in the context of significant concomitant use of acid reducing agents in the CML population.
“We are very pleased that our product candidate Dasynoc has been granted this orphan drug designation. This is our second product candidate to be granted this designation and it confirms both our technology and the unmet medical need that Xspray Pharma can address. This strengthens us in our goal to work with improved oncology pharmaceuticals and to provide patients a better quality of life”, said Per Andersson, CEO of Xspray Pharma.
Dasynoc is Xspray Pharmas first product candidate and is currently under FDA review for approval. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
Chronic myeloid leukemia – CML
CML is a type of blood cancer where the body produces malignant white blood cells. Almost all patients with CML have an abnormality known as the "Philadelphia chromosome," which produces a protein called BCR-ABL. This protein aids the proliferation of malignant white blood cells in affected patients. About 15% of all leukemia is CML. In 2020 it was projected that 8,450 people in the US would be diagnosed with CML and in 2017, there were an estimated 58,000 people living with the disease in the US.