Xspray Pharma (XSPRAY) FDA Announcement summary

Details of approval or decision

• FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Dasynoc due to GMP observations at a contract manufacturer.

• No issues were found with the production line used for Dasynoc, but FDA is pausing new product approvals at the facility until corrective actions are completed.

• FDA requested additional information to confirm the appropriateness of the proposed product information and data on previously implemented corrective actions.

Impact on industry and stakeholders

• Launch of Dasynoc is delayed due to manufacturing issues outside the company's direct control.

• The company is working closely with the manufacturer and FDA to expedite the process and enable resubmission after corrective actions.

• Other development programs, including XS003 (nilotinib), are progressing as planned, with an NDA review expected to start soon.

Scientific data and evidence

• Dasynoc is an amorphous form of dasatinib, showing bioequivalence at a 30% lower dose due to improved solubility.

• The drug is compatible with proton pump inhibitors, which are commonly co-prescribed to CML and ALL patients.