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.
However, as of May 9, 2019, Chimerix discontinued its clinical trials of both oral and intravenous brincidofovir for the treatment of adenovirus infections. The Company plans to make the existing clinical supply of oral brincidofovir available to patients with serious adenovirus or poxvirus infections as part of the expanded access program.
For clinical trials being conducted in this or other specific disease indication(s), patients and their physicians can search for relevant terms on clinicaltrials.gov, the U.S. National Institutes of Health clinical trial database.
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:
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 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.