Expanded Access Policy for Investigational Medicines
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.
Spero’s Expanded Access Policy:
Spero Therapeutics is committed to advancing novel treatment approaches for bacterial infections. Further, Spero is dedicated to delivering differentiated medicines to help patients suffering from serious rare diseases and MDR bacterial infections.
As part of that commitment, Spero conducts clinical trials of our investigational medicines to evaluate their safety and effectiveness for our patients. The data generated from these clinical trials are used to obtain regulatory approval of our medicines, and it is the most fair and efficient means of making them available to those in need. Therefore, the company’s position is that enrollment in a Spero-sponsored clinical trial is the preferred route of access to our investigational drug candidates. Clinical trials ensure rigorous evaluation and oversight of all patients involved. Information about ongoing clinical trials is posted at:
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None of Spero’s investigational drug products are available for expanded access at this time.
Patients should consult with their healthcare professional if they are interested in learning if enrolling in a clinical trial is an option for them. Patients and caregivers can also learn more about clinical trials here:
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You are leaving www.sperotherapeutics.com
Please note that Spero Therapeutics, Inc. is not responsible for the content or services of that site or any further links from that site. Spero Therapeutics, Inc. is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site or its content by Spero Therapeutics, Inc. Please be aware that the linked site may be governed by its own set of terms and conditions and privacy policy, for which Spero Therapeutics, Inc. has no responsibility.
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For additional information about Spero’s clinical trials, please contact: expandedaccess@sperotherapeutics.com
Spero’s Expanded Access policy is subject to change at Spero’s sole discretion. Updates to the policy will be posted here.
