Expanded Access

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.
  • Providing investigational medicine through expanded access will not compromise clinical trials or the regulatory pathway.

Physicians seeking expanded access to a Chimerix investigational product on behalf of their patient should submit an inquiry to expandedaccess@chimerix.com. Chimerix will promptly acknowledge receipt of requests from treating physicians, generally within 24-48 hours of receiving the request for information. Physicians will then be directed to submit required documentation to Chimerix. Medical professionals at Chimerix who are familiar with the data collected on the investigational drug will evaluate the request based on the scientific evidence available at the time of the request. Chimerix will strive to respond to the treating physician within five business days of the receipt of required medical documentation. If Chimerix supports the request for investigational medicine, final approval from regulatory bodies then follows as per applicable national legislation. 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.

TEMBEXA®

TEMBEXA (brincidofovir) was approved by the FDA on 04 Jun 2021 for the treatment of smallpox. TEMBEXA is not available for commercial sale. Chimerix expects to work globally with governments and public health agencies to make TEMBEXA available for use in case of a smallpox outbreak. TEMBEXA is not available through expanded access. In September 2019, Chimerix exclusively licensed the global rights to develop brincidofovir for all non-orthopoxvirus indications to SymBio Pharmaceuticals Ltd. (Tokyo, Japan). Please direct any inquiries about the use of brincidofovir in these other indications (e.g., adenovirus) to SymBio Pharmaceuticals at https://www.symbiopharma.com/pipeline.

DSTAT

Dociparstat is not available through expanded access. All drug supplies are being directed to clinical trials to determine the safety and efficacy of DSTAT in the setting of acute myeloid leukemia (AML).

ONC201

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.