Expanded Access Policy

Expanded Access Policy

Equillium’s mission is to develop innovative therapies to treat patients with severe immuno-inflammatory disorders. We are committed to providing patients with access to approved treatments as quickly as possible and in alignment with policies and guidelines established by regulatory agencies.

Equillium puts patients first and recognizes the importance of developing a policy around expanded access, often referred to as “Compassionate Use.”

We understand the need for expanded access and our goal is to provide study drug access at the appropriate time and in the correct context for patients.

We have reviewed the following considerations to determine whether or not to offer our investigational drug products for expanded access at this time:

  • Is there strong data to support the drug’s safety and efficacy so that it can be provided outside of a clinical trial?
  • Will safety data, which is necessary to meet regulatory approval, be adequately provided to Equillium by a local physician outside of a sponsored clinical trial?
  • Is there adequate supply to provide the drug to all equally qualified expanded access patients and for our clinical development programs?
  • Will it jeopardize our ability to bring a therapeutic to market as quickly and to as many patients as possible?

After evaluating these considerations, Equillium has determined that expanded access for the investigational drug products cannot be offered at this time. This policy will be re-assessed periodically. Although expanded access is not currently offered, prospective patients are encouraged to consult with their healthcare provider about participating in ongoing clinical studies of itolizumab.

If you have questions about Equillium’s expanded access Policy, please contact Equillium’s Medical Information at: medinfo@equilliumbio.com.