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.
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/