Chimerix’s mission is to develop innovative medicines that address significant, unmet medical needs. Chimerix believes that the best way to ensure that patients in need have broad, rapid access to its medicines is by establishing safety and efficacy in clinical trials that lead to marketing authorization by regulatory authorities.
To participate in a clinical trial, patients must meet specific criteria that are designed to help researchers collect accurate and meaningful results while, at the same time, also helping to mitigate risk. There are risks associated with any medical treatment, including investigational therapies being studied in a trial. Informed consent is a critical part of the clinical trial enrollment process and is designed to ensure patients understand the potential risks of participating in a specific trial.
In cases where a clinical trial is not an option, Chimerix may elect to provide physician-requested expanded access to its investigational medicines in the U.S. and other countries where Chimerix intends to submit an application for marketing authorization of the requested product. 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:
Information on open Chimerix expanded access protocols is available here. Physicians seeking expanded access to a Chimerix investigational product on behalf of their patient should submit an inquiry to firstname.lastname@example.org. 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.
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.