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FDA Accepts CML Drug Submission Following Rejection

April 3, 2024

May 2024

The U.S. Food and Drug Administration (FDA) accepted Xspray Pharma’s resubmission of dasatinib for the treatment of chronic myeloid leukemia (CML) after a rejection in 2023. The Prescription Drug Use Fee ACT (PDUFA) date is set for July 31, 2024.

Xspray’s formulation of dasatinib has faced not only FDA rejection, but also patent litigation with Bristol Myers Squibb. Xspray touts the formulation as an optimized version of dasatinib and seeks to outperform Bristol’s formulation by becoming best-in-class.

Advantages to the formulation include more even and consistent uptake of dasatinib, the potential for fewer side effects due to its ability to be administered at a lower dose, and immunity to the effects of the pH value of the stomach, according to Xspray.

“With the new timeline communicated by the FDA, I am pleased to confirm that Xspray Pharma is on track to launch our lead product candidate [dasatinib] on September 1 if approved, as previously communicated,” said Per Andersson, chief executive officer of Xspray Pharma AB. “We appreciate the FDA’s diligent review of our resubmission and look forward to collaborating closely with the agency in the lead-up to the PDUFA date.”

Sources: Fierce Pharma, February 12, 2024. Business Wire, February 12, 2024.

 

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