Expanded Access Policy for Investigational Medicines – U.S. Only
The main purpose of a clinical trial is to gain information about the safety and efficacy of an investigational drug product in order to submit a marketing application to FDA in support of an approval to market the drug in the United States. An investigational product is a drug product that has not been approved by FDA. Expanded access refers to the use of an investigational product outside of a clinical trial in the setting of a serious and life-threatening illness where there are no other treatment options, potential patient benefit justifies the potential risks of treatment, and providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
None of Spero’s investigational drug products are available for expanded access at this time.
It is Spero’s position that direct enrollment in a Spero-sponsored clinical trial is the preferred route of access to the investigational drug product.
Spero’s Expanded Access policy:
- Applies to the United States only.
- The investigational drug is under active clinical development with adequate information to understand benefit-risk, as well as determine an appropriate dose and schedule for the patient’s condition. Typically, this means that at least one clinical trial evaluating the investigational drug in patients has been completed.
- Drug supplies must be adequate to support ongoing clinical trials, the conduct of which cannot be jeopardized.
- The patient for whom the request is being made, must have a serious or life-threatening illness that is potentially treatable by the investigational drug and for which there are currently no other available effective treatment options and patient enrollment in a clinical trial is not possible.
Requests for drug through Expanded Access:
- Must be submitted by a US-based licensed treating physician who will assume all responsibilities for the investigational drug product under an IND in accordance with US laws and regulations.
- Requests must be submitted to the following email address: expandedaccess@sperotherapeutics.com
- Spero will review requests on an individual case basis and respond within five business days.
None of Spero’s investigational drug products are available for expanded access at this time.
This policy is subject to change at Spero’s sole discretion. Updates to the policy will be posted on this website.
Information about Spero’s ongoing development pipeline can be found here: https://sperotherapeutics.com/pipeline/
