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, the safety and effectiveness of vamorolone has only been tested in small numbers of patients with Duchenne muscular dystrophy at low doses and for short courses. Thus, until more data is available, ReveraGen BioPharma is not considering requests for expanded access outside of clinical 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.