Investigational medicines for patients who need hope
Chimerix Approach to Expanded Access
In cases where a clinical trial is not an option, Chimerix may elect to provide physician-requested expanded access to its investigational medicines. Treating physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking expanded access to unapproved medicines. Chimerix will consider requests for access to its investigational medicines, as permitted by applicable law, in very specific circumstances, when all of the following criteria are met:
- The patient has a serious or immediately life-threatening disease for which no alternative therapies are currently available.
- The expanded access program is authorized for the requested indication.
- There are adequate supplies of the drug available for use.
- There is adequate clinical evidence of a positive benefit to risk profile for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
- The patient does not qualify for a Chimerix clinical trial.
- There are no satisfactory alternative treatments available.
- Providing investigational medicine through expanded access will not compromise the initiation, conduct or completion of a clinical study program that is required for approval of investigational medicines.
Physicians seeking expanded access to a Chimerix investigational product on behalf of their patient should submit an inquiry to [email protected]. Chimerix will promptly acknowledge receipt of requests from treating physicians, generally within 24-48 hours of receiving the request for information. Requests must not include the patient’s name or specific identifying information. There is no guarantee that an expanded access request will be granted. Physicians who receive a Chimerix investigational medicine for their patients through the expanded access program must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, and protection of intellectual property. This policy is subject to change. Chimerix will revisit the policy periodically and amend it as appropriate.
In September 2022, Chimerix sold TEMBEXA to Emergent BioSolutions. For more information, visit Emergent’s website.
The ONC201 Expanded Access Program (EAP) has been made available to select hospitals across the United States. A list of centers that are open for enrollment or in the process of initiating the program can be found on clinicaltrials.gov along with their contact information. Patients and their families can reach out directly to these centers to discuss treatment options and enrollment timelines, as enrollment activities must be completed by the treating physician and their respective institutions in collaboration with Chimerix before a patient can be treated.
Requests for Expanded Access need to be submitted by a U.S. based physician familiar with the patient’s medical history. Families and patients can reach out directly to participating hospitals to evaluate clinical trial options. Contact information for these centers can be found on clinicaltrials.gov.
Chimerix does not provide expanded access for ONC206
- How do patients apply to the ONC201 Expanded Access Program?
Requests for Expanded Access need to be submitted by a U.S. based physician familiar with the patient’s medical history. Families and patients may reach out directly to participating hospitals to evaluate treatment options. Contact information for these centers can be found on clinicaltrials.gov: click here.
- How can I find out if a patient qualifies for the ONC201 Expanded Access Program?
Patients and caregivers who are interested in our investigational medicine shold first inquire with their physician if the patient would be eligible for a Chimerix enrolling clinical trial. If a patient is eligible for a Chimerix enrolling clinical trial, they will not be eligible for the Expanded Access Program. Eligibility criteria and a list of participating hospitals for Chimerix’s clinical trials and for the Expanded Access program are available on clinicaltrials.gov: click here. Eligibility for a specific patient is always determined by the treating physician in tandem with Chimerix’s medical team. Please reach out directly to a participating hospital to determine eligibility.
- Is there an age requirement to participate in the ONC201 Expanded Access Program?
There is no age requirement for the ONC201 expanded access program. There is a minimum body weight required to participate; all patients must be ≥ 10kg.
- Does the ONC201 Expanded Access Program include newly diagnosed patients? Does it include patients in progression?
For patients who do not qualify for a clinical trial and meet the other guidelines for consideration in the EAP program, the program may allow DIPG patients to start ONC201 as soon as 14 days after completion of radiation therapy, regardless of whether their disease has progressed or not. Patients who have a glioma diagnosis other than DIPG who are otherwise eligible for the ONC201 Expanded Access program may start ONC201 after completion of radiation and subsequent disease progression.
- What is the cost to the patient for the ONC201 Expanded Access Program?
Chimerix provides ONC201 free of charge to participating hospitals, and hospitals are not allowed to charge for ONC201 itself. However, the cost of medical care for the patient may vary, depending on insurance and the local hospital. Please contact one of the participating centers to discuss the cost you may incur from your care provider.
- Our family is located outside of the United States. Can we apply for the ONC201 Expanded Access Program?
Currently Chimerix only distributes ONC201 expanded access to specific U.S.-based hospitals participating in the Expanded Access program. International patients are eligible for the Expanded Access program as long as they can be treated by a U.S. physician at one of the participating U.S.-based hospitals.
How does Chimerix use the information submitted?
Chimerix will use the information submitted to evaluate requests for access to its investigational medicines, and as described in its Privacy Policies.
How does Chimerix protect information submitted to its Expanded Access Program?
Chimerix has in place appropriate privacy and security policies which are intended to ensure, as far as
reasonably possible, the security and integrity of all our information, including information submitted by you, whether the information is your personal information or pertains to another individual (e.g., the patient), however, as previously noted, requests for expanded access should not include patient identifiable information. For more information about Chimerix’s processing of personal data, including how, why, and on what lawful bases Chimerix processes personal data, please read our Privacy Notice.