Expanded Access Policy
X4 Pharmaceuticals, Inc. Policy on Expanded Access to Investigational Drugs
Clinical trials, and the subsequent approval of a therapy, provide the best way to provide long-term access to new therapies to as many patients as possible. Patients interested in an investigational product which has not yet been approved are encouraged to speak with their doctor and potentially participate in one of X4’s current or future clinical trials. Please find information on clinical trials by searching for X4 Pharmaceuticals at www.clinicaltrials.gov.
Currently, X4 is only offering expanded access to patients who were enrolled in an X4-sponsored long-term extension study at the time that it was terminated. The expanded access program will be administered via a single patient Investigational New Drug (IND) application process managed by the treating physicians. A single patient IND is a written request by a physician for individual patient use of an investigational drug that is submitted to the FDA or comparable regulatory agencies in other countries.
We encourage you to stay informed regarding our development programs and, as more information and clinical data on the safety and efficacy of mavorixafor becomes available, our policy on expanded access will be reviewed on a regular basis.
For additional information, physicians with eligible patients can contact X4’s Medical Affairs team at firstname.lastname@example.org.
Patients and families interested in learning more about expanded access generally can visit the Expanded Access Navigator or contact X4’s Patient Affairs and Advocacy team at email@example.com.