FRONTIER BIOTECHNOLOGIES Inc.

Expanded Access Policy

 
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At Frontier, we commit to bringing new, innovative therapies to patients by conducting rigorous clinical trials and obtaining marketing approval by the FDA and other regulatory authorities. For people seeking access to investigational medicines before they are approved by a regulatory authority, participation in clinical trials is the first and most preferable route. Frontier conducts clinical trials to study the investigational medicines in patients in which the studies are designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessibility to patients. To learn more about available clinical trials from Frontier, please visit clinicaltrials.gov and search by company, disease or medicine.

In certain circumstances, however, when patients have exhausted all available medical options and participation in clinical trials is not an option, Frontier may consider providing an investigational medicine outside of a clinical trial. This is called "Expanded Access". Expanded Access, also known as "Compassionate Use", "Early Access", and "Emergency Use", may be an option for a limited number of individuals with serious or life-threatening conditions, who have exhausted all available medical options and is not possible for them to enroll in clinical trials. List of criteria for being eligible for expanded access is provided below:

The patient has a serious or life-threatening illness with no comparable or satisfactory alternative therapies. The patient is ineligible for, or otherwise unable to, participate in a clinical trial.The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational medicine and the benefit outweighs the known or anticipated risks.The investigational medicine is currently in clinical development - that is, it is currently being studied in humans.Providing the investigational medicine for the requested use will not interfere with the initiation, conduct, or completion of clinical trials that could support an investigational medicine’s development or marketing approval for the treatment indication.The company has an adequate supply of the investigational medicine for Expanded Access Program.

For more information about expanded access in the U.S., please visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.

Frontier's Policy with Regards to the Expanded Access

Individual patient expanded access is managed by the patient's physician. We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial.

At this point of time, Frontier believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. We do not currently provide our investigational drugs for use through expanded access. Should the circumstance permits change to our expanded assess policy, updates with the instruction for requesting the expanded access will be posted to this website. In the mean time, questions with regards to the expanded access to combination regimen of Albuvirtide (ABT) + 3BNC117 may still be sent to us. Frontier will endeavor to acknowledge receipt of any expanded access questions within 10 business days of receipt.

No requests for the expanded access to combination regimen of Albuvirtide (ABT) + 3BNC117 can be reviewed at this moment. After the expanded access becomes available, the official requests will be reviewed and evaluated. The request for access to a Frontier investigational medicine will only be considered if the patient's treating physician is committed to, and supportive of, the requested treatment.

Contact information

If you are interested in learning more about Frontier’s expanded access program, please contact expandedaccess@frontierbiotech.com.

Content current as of: 11/15/2019

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