- PURPOSE
The purpose of this policy is to inform patients and treating physicians of Phanes Therapeutics, Inc.’s Expanded Access Policy to provide our investigational medical product prior to approval for prescription use. For more information about Expanded Access, please visit the US Food and Drug Administration (FDA) web site (https://www.fda.gov/news-events/public-health-focus/expanded-access).
- POLICY
Eligibility Requirements
Patients are eligible to be included in the Expanded Access program if the following criteria apply:
- Patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to treat the disease or condition. Patient must have exhausted all available standard of care therapies before being considered into the Expanded Access program.
- Patient enrollment in a clinical trial is not possible. Participating in a clinical trial is still the best way to get access to any investigational medical product. For information regarding ongoing clinical trials of investigational medical products, please visit ClinicalTrials.gov.
- Potential patient benefit justifies the potential risks of treatment. Before the investigational medical products are available for Expanded Access, there must be sufficient data collected from ongoing clinical trials to perform a benefit-risk analysis to support the dosage, safety and efficacy of the treatment for the patient’s disease.
The investigational medical product has not yet received regulatory approval, therefore, the potential risk and benefit profiles have not been fully established. The treating physician and patients should consider all possible benefits and risks when seeking expanded access to the investigational medical product.
Providing the investigational medical product will not interfere with investigational trials that could support an investigational medical product’s development or marketing approval for the treatment indication. Although we are providing early access to patients, our priority is to the patients currently enrolled in our clinical trials to prevent any regulatory approval delays. Expanded Access is available only when sufficient drug supply is available.
- Treating Physician Criteria and Responsibilities
The treating physician must be properly licensed to administer the investigational medical product. All requests for Expanded Access of the investigational drug will be reviewed in a fair and timely manner and are to be provided by the treating physician. Phanes Therapeutics, Inc. may require additional information to accurately assess the request. The treating physician is responsible for ensuring any regulatory requirements and approvals are fulfilled, including patient’s informed consent, monitoring, and safety reporting.
Treating physicians seeking early access to the investigational drug for their patients with no alternative treatment options, or have any questions, are to email all requests to
moc.x1714916551tsena1714916551hp@sl1714916551airt-1714916551lacin1714916551ilc1714916551.
Please allow 5 business days to respond to the early access request.
- Termination of Early Access
Your access to the investigational medical product may be changed or stopped without your consent at any time by the treating physician, the Sponsor, or the FDA. Reasons for termination may include: (1) you no longer meet the eligibility criteria for continuing the access. (2) the treating physician feels it is in your best interest to stop receiving the treatment.
Once the investigational medical product receives approval for prescription use, Phanes Therapeutics, Inc. will phase out the Expanded Access program to facilitate the prescription to be provided in the typical manner. The Expanded Access program will also be terminated if the investigational medical product is determined by Sponsor or the FDA to be ineffective and/or unsafe based on data collected from clinical trials.
