Xspray Pharma submits application for market approval to FDA for its product candidate Dasynoc

Press release 2021-11-18

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that the application for US market approval of its first product candidate Dasynoc (dasatinib) has been submitted, in accordance with plans, to the Food and Drug Administration (FDA) under the 505(b)(2) NDA procedure, which is the registration path that applies to improved drugs.

The application consists of the results from the registrational studies on healthy volunteers, where bioequivalence was achieved at about 30 percent lower dosage than the original drug, Sprycel®. The studies confirms that:

  • Dasynoc™ is unaffected by the pH value of the stomach, and can thus be used in combination with proton-pump inhibitors such as omeprazole for treatment of peptic ulcers
  • Dasynoc™ has significantly lower variability than Sprycel, and did not demonstrate cases where there was no uptake of dasatinib at all in the subjects
  • the uptake of Dasynoc is not affected by food intake
  • Dasynoc™ can be administered at a lower dosage than the reference product, which is expected to yield fewer side effects

Under the application procedure, the FDA has up to 60 days to conduct an initial review of the company’s application, and afterward will announce whether the application is ready to continue to a complete review or if additional information is needed. If the application moves on to a full review, approval will take ten months but may also take longer depending on the questions from the FDA during the review process. The application will be supplemented with stability data for lower dosages of Dasynoc™. The point in time at which this is to be done will be determined in consultation with the FDA.

The application includes Dasynoc for the treatment of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), which are blood cancer indications in an area where only one new drug has been registered for a number of years. The leading product, Sprycel®, sold globally for USD 2.1 billion in 2020, of which USD 1.3 billion was in the US.

“This is our first application for market approval, and it marks a major milestone for Xspray Pharma. Our unique technology is especially suited to overcoming many of the shortcomings that PKI substances generally possess, and the technology is applicable to a majority of the 72 PKIs being marketed today. In this way, we are now developing a portfolio of improved PKI drugs that create value for the company and make better quality of life possible for patients,” says CEO Per Andersson.