Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that it has resubmitted to the US Food and Drug Administration (FDA) the New Drug Application (NDA) for its investigational candidate, Yosprala (PA32540/PA8140) for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
Secondary prevention with aspirin may be recommended in patients who have had a myocardial infarction or unstable angina pectoris, chronic stable angina pectoris and those who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated and ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli.
Aralez resubmitted the NDA in response to a Complete Response Letter (CRL) from the FDA in which the only deficiencies identified related to findings by the FDA during an audit of the manufacturing facility of the active pharmaceutical ingredient aspirin (API) supplier. The NDA resubmission includes a new primary aspirin API supplier, together with an alternative supplier intended to address the deficiencies the FDA outlined in the CRL. Final agreement on draft product labeling is also pending.
The FDA is expected to issue Aralez an acknowledgment letter within 30 days of resubmission as to whether the resubmission addresses all the deficiencies identified in the CRL. If accepted, this acknowledgement would also include a new Prescription Drug User Fee Act (PDUFA) date.
"We are pleased to resubmit the NDA package for Yosprala," said Adrian Adams, chief executive officer of Aralez. "Depending on acknowledgement and feedback from the FDA, the PDUFA date could be early fourth quarter of this year. We believe that, if approved, Yosprala has the potential to help millions of adults at risk for aspirin-induced ulcers. This is an important milestone for Aralez and underscores our commitment to providing cardiovascular treatment options to patients in need."