FDA Accepts Resubmitted NDA for Dasynoc in CML and ALL

• Dasynoc is an optimized version of dasatinib (Sprycel), aiming to offer several advantages like improved patient properties and a strong patent position for amorphous dasatinib products.
• Previously, the FDA rejected the application but acknowledged the drug's stability and clinical data. They requested more information on dosing and the manufacturing facility.
• With the Prescription Drug User Fee Act (PDUFA) date approaching and patent issues resolved, Xspray is preparing for a September 1, 2024, launch of Dasynoc, pending FDA approval.

The resubmission of the new drug application (NDA) for Dasynoc for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) has been accepted by the FDA. A PDUFA date of July 31, 2024, has been set.¹

Dasynoc is an optimized version of dasatinib which has the potential to become a best-in-class product with a strong patent position for amorphous dasatinib products with improved properties for patients with CML. Dasynoc is being investigated at 6 dose levels, including 15 mg, 36 mg, 50 mg, 57 mg, 70 mg, and 100 mg.²

This regulatory decision follows the issuing of a complete response letter where the FDA requested additional information surrounding the dosing of the agent and greater clarity around a third-party manufacturing facility.² Despite the FDA issuing the initial rejection, the agency signed off on critical aspects of the application, and they did not identify any deficiencies pertaining to the stability or clinical data of Dasynoc.

Red blood cells: © vipman4 - stock.adobe.com

“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 Dasynoc on September 1 if approved, as previously communicated. 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,” said Per Andersson, chief executive officer of Xspray Pharma AB, in a press release.¹

With the PDUFA date of July 31, 2024, approaching, the company, Xspray Pharma, is finalizing its preparations for the commercial launch of Dasynoc on September 1, 2024. This follows the company's successful resolution of patent litigation with Bristol Myers Squibb, paving the way for Dasynoc to potentially become a new treatment option for CML and ALL pending FDA approval.

Dasynoc, a novel therapy, represents a significant step forward and the company is strategically planning its launch to ensure patients have access to this potential new treatment as soon as possible, following regulatory approval.

REFERENCES:

1. FDA Accepts Xspray pharma’s NDA-resubmission for Dasynoc® – PDUFA date set to 31 July 2024. News release. Xspray Pharma AB. February 12, 2024. Accessed February 12, 2024. http://tinyurl.com/34t6j496

2. FDA rejects Xspray's would-be rival to Bristol Myers' Sprycel on dosing, manufacturing concerns. News release. Fierce Pharma. July 11, 2023. Accessed February 12, 2024. http://tinyurl.com/5549drh9