Expanded Access Policy

In severe or life-threatening conditions where there are no available treatment options, regulators may grant permission to provide a treating physician access to an unapproved drug; this is known as expanded access.

At this time, expanded access to vamorolone is available only to those eligible patients who have previously or are currently exiting the VBP15-LTE, VBP15-004, and VBP15-006 trials. Thus, until more data is available, ReveraGen BioPharma is not considering requests for expanded access for patients outside of those previously enrolled in these three vamorolone trials.

Additional information on expanded access is available at https://www.clinicaltrials.gov/ct2/show/NCT03863119. This policy may change.

For questions regarding our current expanded access policy, please contact Eric Hoffman, ReveraGen BioPharma at eric.hoffman@reveragen.com.