CorMedix Policy on Expanded Access to Investigational Products
for the Prevention of Catheter-Related Bloodstream Infections
Infections are a significant threat to the health and well-being of patients requiring the use of long-term central venous catheters. According to the Joint Commission, there are 100,000 estimated deaths in the US annually due to healthcare-acquired infections with one-third from catheter-related bloodstream infections alone.[1] Despite significant reductions in recent years in central-line-associated bloodstream infections through improvements in hand-washing hygiene, better sterile technique and post-placement care, reducing these infections remains an unmet medical need. CorMedix supports the development of new products that will improve the lives of patients and combat serious, life-threatening diseases, including catheter-related bloodstream infections.
Because there are currently no drugs approved for the prevention of CRBSI, some patients who experience recurrent infections may have no options to address this serious condition. In certain circumstances, access to investigational medications may be a viable option. We hope that patients in need will first seek to join one of our clinical trials, if they are in progress.
Because CorMedix is committed to using rigorous scientific research to develop evidence-based anti-infective therapies, availability of investigational products will be limited by the needs of the clinical trial and clinical development program, and we cannot guarantee that every request for pre-approval access will be granted. By ensuring that our clinical development program continues, CorMedix can work toward meeting the regulatory requirements that will enable the company to make the products available to a broad population through regulatory review and approval.
While we work diligently to develop new and innovative solutions to combat infections, we cannot ignore patient safety. As such, all requests for pre-approval access to investigational products must be initiated by a physician treating the patient, who will continue to monitor the patient should access be granted. Because investigational products may not have completed all of the studies needed for regulatory approval, the potential benefit of the product must be considered against the safety of administration of the product to the patient.
Therefore, all requests are evaluated on a case-by-case basis in a fair and equitable manner, by the in-house medical experts at CorMedix. Assessing the risk-benefit of using an investigational product may require CorMedix to request additional information, including patient history, to adequately evaluate the request. CorMedix hopes to respond to requests within 10 business days.
To qualify for the Expanded Access program, the following criteria must be met:
- No other treatment options are appropriate, including ongoing clinical trials or approved products;
- Illness must be serious or life threatening;
- There must be sufficient evidence that the potential benefit to the patient outweighs the risk of the use of the product, based on knowledge existing at the time of the request;
- The requesting physician has no more than 5 patients at a given time receiving pre-approval access to a specific investigational product from CorMedix; and
- Because the regulatory laws vary widely by country, CorMedix will only consider requests from countries in which the company has an established regulatory presence.
At this time, CorMedix is developing catheter lock solutions. As the development of these products has focused on this intended use, the safety of the product as a systemically administered treatment has not been evaluated.
Because the safety profile of a drug intended for use in a catheter is very different than one meant for circulation throughout the body, CorMedix cannot at this time provide treatment to patients whose condition would require use of the investigational product beyond that of a catheter lock. As we continue to develop our investigational products, we will revise this policy and its limitations on use as additional knowledge warrants.
Because patient privacy and safety are of the utmost importance to us, we cannot accept requests directly from patients.
Physicians may contact us at expandedaccess@cormedix.com to request information about our Expanded Access program. We request that no patient identifiers are used in the initial communications.
