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 are exiting the VBP15-LTE and VBP15-004 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 two vamorolone trials. This policy may change as safety and efficacy are better demonstrated.

For questions regarding our current expanded access policy, please contact ReveraGen BioPharma at 301-762-7980.