Therapy Areas: Oncology
XSpray Pharma granted US orphan drug designation for treatment of CML
17 June 2022 -

Swedish pharmaceutical company XSpray Pharma AB (STO:XSPRAY) said on Friday that its product candidate Dasynoc has been granted orphan drug designation (ODD) in the United States for the treatment of chronic myeloid leukemia (CML), a type of blood cancer.

The decision by the US Food and Drug Administration (FDA) was based on the plausible hypothesis that Dasynoc may be clinically superior to the same drug(s) already approved for the same indication 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.

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.